FDA UDI In Commercial Distribution 🇺🇸 United States

TC May Hegar Needle Holder 20cm

DI: G25004023200 · Model: 04-023-20 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TC May Hegar Needle Holder 20cm
Primary DI
G25004023200
Version / Model
04-023-20
Catalog Number
04-023-20
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-26
Public Version
1
Public Version Date
2023-05-04
Public Version Status
New
Public Device Record Key
80a6f1d3-281f-4005-ac7a-23c26614c6cb

Device Description

A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
["Ultraviolet Light", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
FHQ Holder, Needle, Gastroenterologic

GMDN Terms

Code Name
12726 Suturing needle holder, reusable

Identifiers

Type ID
Primary G25004023200

Device Sizes

Type Value Unit Text
Length 20 Centimeter