FDA UDI In Commercial Distribution 🇺🇸 United States

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

DI: 03701037318294 · Model: 924-0909 · FX SOLUTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Primary DI
03701037318294
Version / Model
924-0909
Catalog Number
924-0909
Company Name
FX SOLUTIONS
Labeler DUNS
263076196
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-31
Public Version
1
Public Version Date
2023-02-08
Public Version Status
New
Public Device Record Key
daebc317-9a18-47ff-a04d-d44bd7020f58

Device Description

TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY Ø40+9 / TAPER Ø10

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
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
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
44054 Orthopaedic surgical procedure kit, non-medicated, reusable

Identifiers

Type ID
Primary 03701037318294