Model: P45-990-0001
Catalog: P45-990-0001
DI: 00889795152862
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Tibial Frame Cover
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2b8f1363-69c3-4261-872a-723fe8baf850
Distribution Status:
In Commercial Distribution
DUNS Number:
042961576
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:
00889795152862
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67571
Name: External orthopaedic fixation system noninvasive component, single-use
Definition:
A noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.
FDA Product Codes
FZX
Guide, surgical, instrument