Device
The SleeveLUX 16 Proctoscope is a class 2, self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the a...
Manufacturer
Haemoband Surgical
Haemoband Surgical
Model: P2002
Catalog: P2002
DI: 05060937770020
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
The SleeveLUX 16 Proctoscope is a class 2, self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids. The SleeveLUX 16 Proctoscope must only be used by trained professionals.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fe72360a-b47b-4808-9a15-20f822d0b853
Distribution Status:
In Commercial Distribution
DUNS Number:
214125792
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
15060937770027
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
30
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05060937770020
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05060937770020
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44914
Name: Optical anoscope, single-use
Definition:
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.
FDA Product Codes
FER
Anoscope And Accessories
Premarket Submissions
Submission Number:
K250645
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
5
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature