FDA UDI In Commercial Distribution 🇺🇸 United States

Splinter Forceps

DI: G165SU80395110 · Model: SU-8-0395-11 · ELMED INSTRUMENTS(PVT)LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Splinter Forceps
Primary DI
G165SU80395110
Version / Model
SU-8-0395-11
Catalog Number
SU-8-0395-11
Company Name
ELMED INSTRUMENTS(PVT)LTD.
Labeler DUNS
645680588
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-08
Public Version
1
Public Version Date
2022-09-16
Public Version Status
New
Public Device Record Key
9310ffb1-8303-455b-becc-ade4b8dd706e

Device Description

Intended Use: uses including removal and placement of wound closure adhesive strips, suture removal, and holding suture ends prior to cutting Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEN Forceps, General & Plastic Surgery

GMDN Terms

Code Name
62479 Surgical soft-tissue manipulation forceps, tweezers-like, single-use

Identifiers

Type ID
Primary G165SU80395110