FDA UDI In Commercial Distribution 🇺🇸 United States

GLOBAL UNITE™ Short Stem Instrumentation

DI: 00847538018561 · Model: 210005120 · SYMMETRY MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GLOBAL UNITE™ Short Stem Instrumentation
Primary DI
00847538018561
Version / Model
210005120
Company Name
SYMMETRY MEDICAL INC.
Labeler DUNS
079881212
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-01
Public Version
1
Public Version Date
2021-09-09
Public Version Status
New
Public Device Record Key
bc799fc7-2474-4d78-81be-303d307c3bde

Device Description

SHORT PRX HUM BROSTEOTOME 12MM

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
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
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
36167 Orthopaedic broach

Identifiers

Type ID
Primary 00847538018561