AccessGUDID - DEVICE: Fisch-McGee wire closing forceps (04250381848739)

GUDID

Device Identifier (DI) Information

Brand Name: Fisch-McGee wire closing forceps
Version or Model: 10-712-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-712-00
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250381848739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: 0.6x3.5 mm, straight, 8 cm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32886	Wire holding/twisting forceps	A surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNQ	FORCEPS, WIRE CLOSURE, ENT, NON-STERILE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 363fcef2-6a4a-4d65-9f98-7842936fae99
Public Version Date: September 21, 2022
Public Version Number: 1
DI Record Publish Date: September 13, 2022