Model: AR-9953AL-09S
Catalog: AR-9953AL-09S
DI: 00888867504493
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Anatomic Prox Humeral Plate, Lt, 9H,Strl
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a566331f-8b00-4a59-8afd-c90975108cfb
Distribution Status:
In Commercial Distribution
DUNS Number:
131747628
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:
00888867504493
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46647
Name: Orthopaedic fixation plate, non-bioabsorbable
Definition:
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
HRS
Plate, fixation, bone