AccessGUDID - DEVICE: Novo Surgical Inc. (00842331148545)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical Inc.
Version or Model: UR6271-29L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UR6271-29L
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331148545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: dittel urethral sound, straight, 11 1/2" (29.2 cm), 18 fr.

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:	Yes
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?
11265	Urethral dilator, reusable	A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBX	Sound, Urethral, Metal Or Plastic

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
No Device Sizes

Device Record Status

Public Device Record Key: 93007c79-ce9a-4c37-baa9-502f8b16edf6
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 12, 2022