AccessGUDID - DEVICE: NA (04250480102985)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 41.0611a.wol
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SCHÖLLY FIBEROPTIC GmbH

Primary DI Number: 04250480102985
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316276682 *Terms of Use

Device Description: Uretero-Renoscope 7.5 Fr. x 310 mm, Working channel 5 Fr.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37112	Rigid optical ureterorenoscope	An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGB	Ureteroscope And Accessories, Flexible/Rigid

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
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Working length 310 mm
Device Size Text, specify: Insertion tube outer diameter (distal end) 7.5 Fr.

Device Record Status

Public Device Record Key: c27b4a9f-8b74-4b69-b8de-ff95d3bdff8c
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: July 17, 2018

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9999999999
Email: info@schoelly-usa.com

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