AccessGUDID - DEVICE: n.a. (04048551050248)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 11003MA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551050248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Biopsy Forceps, flexible, 1 mm

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
Surgical biopsy forceps	A hand-held manual surgical instrument designed to obtain biopsy specimens from tumours or other tissues during an open surgical procedure or via a large natural orifice, e.g., vagina or rectum, for histopathological examination. It is typically a long, rigid instrument constructed of high-grade stainless steel whose distal ends are equipped with two cutting heads with sharp edges, one fitting exactly into the other, or scissors-like cups with a cutting edge around their rim which facilitates the cutting of the biopsy; these are operated by scissors-like ring handles at the proximal end. It is available in various sizes. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical biopsy forceps

A hand-held manual surgical instrument designed to obtain biopsy specimens from tumours or other tissues during an open surgical procedure or via a large natural orifice, e.g., vagina or rectum, for histopathological examination. It is typically a long, rigid instrument constructed of high-grade stainless steel whose distal ends are equipped with two cutting heads with sharp edges, one fitting exactly into the other, or scissors-like cups with a cutting edge around their rim which facilitates the cutting of the biopsy; these are operated by scissors-like ring handles at the proximal end. It is available in various sizes. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954797	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: 16c0c0b7-2f0f-4e1a-bf8a-ce0f7d307ac5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016