Model: C
Catalog: S-MAK501NBT
DI: 00884450847367
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-02
Current Version: 2026-05-11
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bb1ca48f-28fa-4702-b9fd-87b335cbbf37
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
10884450847364
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450847367
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450847367
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 42412
Name: Laparoscopic access cannula, single-use
Definition:
A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.
FDA Product Codes
DRE
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Device Sizes
Item #1 - Size Text:
Introducer Length (cm)-10 cm (4")
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Guide Wire Diameter (OD)-0.018" (0.46 mm)
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Needle Gauge (G)-21G
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Introducer French Size (F)-5F
Item #4 - Size Type:
Device Size Text, specify