Model: C
Catalog: RNL-10-038S
DI: 00884450645550
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2dd74abf-4f28-400e-8f5c-f53f706085cb
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10884450645557
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450645550
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450645550
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 11305
Name: Closed-wound drain, non-bioabsorbable
Definition:
A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
FDA Product Codes
GBX
Catheter, Irrigation
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
25
Item #1 - Size Type:
Catheter Length
Item #2 - Size - @attributes - Unit:
French
Item #2 - Size - @attributes - Value:
10
Item #2 - Size Type:
Catheter Gauge