AccessGUDID - DEVICE: E-LINE (04055207018309)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 8650254
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8650.254
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: ADAPTER FOR CYSTOSCOPE only for diagnostics, TL 60mm, compatible with sheaths 86500145, 86500245, 86500345, 86500445, 86500545, 86500645, and telescopes Ø 4mm, 0°/12°/30°/70°, without insertion port, bayonet-cap, 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?
37423	Pin-indexed adaptor, reusable	A connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBO	CYSTOURETHROSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: dbcca9af-4462-4afc-b619-3b798ff2e1c1
Public Version Date: June 22, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016