Device
Rapid Compression Implant - Standard
Manufacturer
Treace Medical Concepts, Inc.
Model: SD33 DI: 00810111227254 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-13 Current Version: 2026-05-21
Description
Rapid Compression Implant - Standard
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 6f309200-05d7-4de1-a7f2-58ac437f78bd
Distribution Status: In Commercial Distribution
DUNS Number: 054808082
Device Count: 1
DM Exempt: No
Premarket Exempt: No
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: 00810111227254
Type: Primary
Issuing Agency: GS1
GMDN
Code:
Name:
FDA Product Codes
JDR
Staple, Fixation, Bone
HWC
Screw, Fixation, Bone
HRS
Plate, Fixation, Bone