AccessGUDID - DEVICE: UroCuff-DC Disposable, Single (00890477000333)

GUDID

Device Identifier (DI) Information

Brand Name: UroCuff-DC Disposable, Single
Version or Model: 730-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SRS Medical Systems, Inc.

Primary DI Number: 00890477000333
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796263598 *Terms of Use

Device Description: No description.

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":	Yes
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?
11111	Cystometer	A device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder. It may also measure the amount of residual urine after the patient has passed water. The device may operate mechanically, by ultrasound techniques, or a combination of both. For more advanced diagnosis/study of the bladder see the appropriate GMDN code.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXQ	Cystometer, Electrical Recording

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: ae507d80-14df-4ac0-92c1-330897bbdadd
Public Version Date: October 07, 2020
Public Version Number: 1
DI Record Publish Date: September 29, 2020