AccessGUDID - DEVICE: n.a. (04048551050248)

GUDID

View all sections | Close all sections

Device Identifier (DI) Information

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

Primary DI Number: 04048551050248
Issuing Agency: GS1
Device Count: 1

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)

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: n.a. (04048551050248)