Model: P62-001-3512-SK
Catalog: P62-001-3512-SK
DI: 00889795141606
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
PCFD Tether Implant Sterile Kit
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
611f31c6-7982-4c52-ab4f-175a1df4d68d
Distribution Status:
In Commercial Distribution
DUNS Number:
042961576
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
Device ID:
00889795141606
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44052
Name: Orthopaedic surgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
MBI
Fastener, fixation, nondegradable, soft tissue
Premarket Submissions
Submission Number:
K253886
Supplement Number:
000