AccessGUDID - DEVICE: NA (04055207045886)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 825300701
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 82530.0701
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207045886
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: OPT. BIOPSY FORCEPS WL 500MM jaw curved upwards, for telescope 0° Ø 4mm, TL 564mm, reusable

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):	No
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?
35732	Rigid endoscopic biopsy forceps, reusable	A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWH	FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)

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
Length: 500 Millimeter

Device Record Status

Public Device Record Key: b8e49143-8a16-4223-aeb5-d718ae4d0b7c
Public Version Date: August 19, 2022
Public Version Number: 3
DI Record Publish Date: September 28, 2016