AccessGUDID - DEVICE: NA (04055207045077)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8990025
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8990.025
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207045077
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: AMNIOSCOPE TUBE ID 12.9MM OD 16/23MM for children, TL 222mm, distal end straight, graduated, 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?
32631	Transcervical amnioscope	An endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted via the vagina, through the maternal uterine cervix and into the amniotic cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HEZ	ENDOSCOPE, TRANSCERVICAL (AMNIOSCOPE)(AND ACCESSORIES)

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
Lumen/Inner Diameter: 12.9 Millimeter

Device Record Status

Public Device Record Key: 94b2ddf0-9104-4ed0-8081-2f45608c7881
Public Version Date: May 26, 2023
Public Version Number: 4
DI Record Publish Date: September 28, 2016