Model: SD34
DI: 00810111227247
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 - 5° Standard
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
372289cd-ab3a-47ef-81e6-9c13de7d75ba
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:
00810111227247
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
JDR
Staple, Fixation, Bone
HWC
Screw, Fixation, Bone
HRS
Plate, Fixation, Bone