FDA UDI In Commercial Distribution 🇺🇸 United States

Debakey Forceps 1.5mm/15cm

DI: G25003140150 · Model: 03-140-15 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Debakey Forceps 1.5mm/15cm
Primary DI
G25003140150
Version / Model
03-140-15
Catalog Number
03-140-15
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-28
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
63e821e5-6b33-49f5-a97f-653c4581c68c

Device Description

A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Ultraviolet Light", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
HTD Forceps

GMDN Terms

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

Identifiers

Type ID
Primary G25003140150

Device Sizes

Type Value Unit Text
Length 15 Centimeter
Device Size Text, specify Tip Width 1.5mm