FDA UDI In Commercial Distribution 🇺🇸 United States

INSTRUMENT

DI: 07613327300635 · Model: I-T0363NE02 · Howmedica Osteonics Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
INSTRUMENT
Primary DI
07613327300635
Version / Model
I-T0363NE02
Catalog Number
I-T0363NE02
Company Name
Howmedica Osteonics Corp.
Labeler DUNS
058311945
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-25
Public Version
4
Public Version Date
2018-10-05
Public Version Status
Update
Public Device Record Key
c9a6ae93-469d-4836-9ef8-347b469c2d99

Device Description

Specialty Gamma 3 Set Screwdriver

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
HSB ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

GMDN Terms

Code Name
33968 Surgical screwdriver, reusable

Identifiers

Type ID
Primary 07613327300635