FDA UDI Not in Commercial Distribution 🇺🇸 United States

First Choice® Modular Ulnar Head System

DI: 10381780282402 · Model: ULNAHDINSTP · Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
First Choice® Modular Ulnar Head System
Primary DI
10381780282402
Version / Model
ULNAHDINSTP
Catalog Number
ULNAHDINSTP
Company Name
Ascension Orthopedics, Inc.
Labeler DUNS
942377524
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-13
Public Version
8
Public Version Date
2023-05-02
Public Version Status
Update
Public Device Record Key
642a46ec-5b53-45a6-8f23-d6fbc256ea15
Distribution End Date
2023-03-31

Device Description

Modular Ulnar Head

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
OJH Orthopedic tray

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Secondary M248ULNAHDINSTP1
Primary 10381780282402

Customer Contacts