AccessGUDID - DEVICE: n.a. (04048551097243)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 26168V
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551097243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Uterine Tenaculum Forceps, 22 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":	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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gynaecological biopsy forceps, reusable	A hand-held manual surgical instrument designed to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues during a surgical procedure for histopathological examination. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. The distal tip usually consists of two shaped cutting heads with sharp edges, one fitting exactly into the other, which facilitates the cutting of the biopsy. It is available in various sizes. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Gynaecological biopsy forceps, reusable

A hand-held manual surgical instrument designed to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues during a surgical procedure for histopathological examination. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. The distal tip usually consists of two shaped cutting heads with sharp edges, one fitting exactly into the other, which facilitates the cutting of the biopsy. It is available in various sizes. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934937	000

Device Exempt from Premarket Submission: No 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: cc2407f3-ff37-416a-adee-4e872a085794
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016