AccessGUDID - DEVICE: NA (04055207038659)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 89101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 89.101
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207038659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SEAL Ø 7.5MM silicone seal, yellow, for instruments 1-5mm, Length 2mm, 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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Endoscope assembly adaptor	A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Endoscope assembly adaptor

A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
GCH	MEDIASTINOSCOPE, DIAGNOSTIC

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 [?]
Ethylene Oxide
Hydrogen Peroxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 7.5 Millimeter

Device Record Status

Public Device Record Key: 2d7ead97-e7e6-447c-a417-88f627244304
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 28, 2016