FDA UDI In Commercial Distribution 🇺🇸 United States

Vasectomy Set of 2

DI: G25003178000 · Model: 03-178-00 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vasectomy Set of 2
Primary DI
G25003178000
Version / Model
03-178-00
Catalog Number
03-178-00
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-29
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
6cc9151f-8d0e-4242-8210-5665927993a2

Device Description

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

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
["Moist Heat or Steam Sterilization", "Ultraviolet Light", "Ethylene Oxide"]

Product Codes

Code Name
HTD Forceps

GMDN Terms

Code Name
44058 General surgical procedure kit, non-medicated, reusable

Identifiers

Type ID
Primary G25003178000

Device Sizes

Type Value Unit Text
Length 14 Centimeter
Length 13 Centimeter