AccessGUDID - DEVICE: MINOP (04046963888909)

GUDID

Device Identifier (DI) Information

Brand Name: MINOP
Version or Model: FH639R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FH639R
Company Name: Aesculap AG

Primary DI Number: 04046963888909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: MINOP inVent Micro Surgical Forceps, working length: 10 1/2", (265 mm), diam. 2 mm, rotatable, toothed (1x2), with tubular shaft, ring handle, double action, consisting of FF433R, FF439R, FH633R, detachable, reusable, to be used with: FH620R

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":	No
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
GZX	INSTRUMENT, MICROSURGICAL

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
Device Size Text, specify: Working length (mm) : 265.000 MM
Device Size Text, specify: Diameter (mm) : 2.000 MM

Device Record Status

Public Device Record Key: e79d2d23-07c2-428f-878a-367a3ac42b75
Public Version Date: September 26, 2022
Public Version Number: 2
DI Record Publish Date: April 24, 2020