FDA UDI In Commercial Distribution 🇺🇸 United States

Sklar®

DI: 10649111389740 · Model: 19-2947 · SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sklar®
Primary DI
10649111389740
Version / Model
19-2947
Company Name
SKLAR CORPORATION
Labeler DUNS
006966006
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-12
Public Version
3
Public Version Date
2019-08-21
Public Version Status
Update
Public Device Record Key
9a7fa376-764d-4f7c-a91e-c0682eb1f3e4

Device Description

HUNTER SPLINTER FCP STR 4 1/4"

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
GEN FORCEPS, GENERAL & PLASTIC SURGERY

GMDN Terms

Code Name
62466 Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Identifiers

Type ID
Primary 10649111389740