FDA UDI In Commercial Distribution 🇺🇸 United States

Debakey Satinsky Forceps 24cm

DI: G25003168240 · Model: 03-168-24 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Debakey Satinsky Forceps 24cm
Primary DI
G25003168240
Version / Model
03-168-24
Catalog Number
03-168-24
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
0ff5011a-ccc0-425b-9fab-a0d7ea90f515

Device Description

A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
62468 Surgical soft-tissue manipulation forceps, scissors-like, reusable

Identifiers

Type ID
Primary G25003168240

Device Sizes

Type Value Unit Text
Length 24 Centimeter