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

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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