FDA UDI In Commercial Distribution 🇺🇸 United States

Sklar®

DI: 10649111194580 · Model: 47-3407 · SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sklar®
Primary DI
10649111194580
Version / Model
47-3407
Company Name
SKLAR CORPORATION
Labeler DUNS
006966006
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-12-03
Public Version
1
Public Version Date
2019-01-03
Public Version Status
New
Public Device Record Key
baf9083c-13e0-4fcf-90cb-0ad98f1b5e59

Device Description

BUNNELL TENDON STRIPPER 7MM 6"

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
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
GAI STRIPPER, VEIN, REUSABLE

GMDN Terms

Code Name
35380 Tendon stripper

Identifiers

Type ID
Primary 10649111194580