Device
RETRA Endoscopic Release System (G2) STERILE For Single Use Only
Manufacturer
A.M. SURGICAL, INC.
A.M. SURGICAL, INC.
Model: 5500-SR
DI: 00857915007040
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
RETRA Endoscopic Release System (G2) STERILE For Single Use Only
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c269a677-045d-4751-ade1-95f24a44a64a
Distribution Status:
In Commercial Distribution
DUNS Number:
160020087
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
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
Device ID:
00857915007040
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58783
Name: Hand ligament surgical release instrument
Definition:
A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.
FDA Product Codes
NBH
Accessories, Arthroscopic