AccessGUDID - DEVICE: Integra® Miltex® (10381780478836)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 29-18-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 29-18-24
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780478836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Walther Urethral Sound, 11-1/4", 24 French

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
Catheter Gauge: 24 French
Device Size Text, specify: 11-1/4"

Device Record Status

Public Device Record Key: f4148de6-90b1-4607-93c8-811d7295b8b9
Public Version Date: May 02, 2023
Public Version Number: 4
DI Record Publish Date: August 16, 2018