FDA UDI Not in Commercial Distribution 🇺🇸 United States

Sonoma Orthopedic Products, Inc

DI: 00816988010791 · Model: 5470 Removal Driver · ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sonoma Orthopedic Products, Inc
Primary DI
00816988010791
Version / Model
5470 Removal Driver
Catalog Number
CS0035
Company Name
ARTHREX, INC.
Labeler DUNS
131747628
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-17
Public Version
6
Public Version Date
2020-07-08
Public Version Status
Update
Public Device Record Key
eb1a3179-e23c-4287-a2b8-28c3a68ca558
Distribution End Date
2020-07-07

Device Characteristics

Single Use
Yes
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
No
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
12696 Orthopaedic implant inserter/extractor, reusable

Identifiers

Type ID
Primary 00816988010791