AccessGUDID - DEVICE: Novo Surgical (G586UR627023L0)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: UR6270-23L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UR6270-23L
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586UR627023L0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: lefort urethral sound, w/ standard 1-56 thread for filiform (not included), 11" (28.0 cm), 12 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:	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?
13643	Urethral sound, reusable	A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. 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: d87f6e86-a273-4a33-8ff1-b952fde74b79
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023