AccessGUDID - DEVICE: Forceps, Needlepulling, TC, Atraumatic 19.5cm tip 3.5mm 6x12 teeth (04057034021057)

GUDID

Device Identifier (DI) Information

Brand Name: Forceps, Needlepulling, TC, Atraumatic 19.5cm tip 3.5mm 6x12 teeth
Version or Model: 10-0642
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-0642
Company Name: Geister Medizintechnik GmbH

Primary DI Number: 04057034021057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343548848 *Terms of Use

Device Description: Forceps, Needlepulling, TC, Atraumatic 19.5cm tip 3.5mm 6x12 teeth spring gold plated, TC(F)

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?
62466	Surgical soft-tissue manipulation forceps, tweezers-like, reusable	A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	FORCEPS, GENERAL & PLASTIC SURGERY

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 712fd0a4-034e-4b3c-9394-3d8766218e13
Public Version Date: September 15, 2023
Public Version Number: 1
DI Record Publish Date: September 07, 2023