AccessGUDID - DEVICE: Poise (10036000491378)

GUDID

Device Identifier (DI) Information

Brand Name: Poise
Version or Model: Pessary
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KIMBERLY-CLARK GLOBAL SALES, INC.

Primary DI Number: 10036000491378
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829568273 *Terms of Use

Device Description: POISE IMPRESSA SIZING KIT BLADDER SUPPORT DEVICE 3

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
61853	Urinary-incontinence vaginal insert, single-use	A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHW	PESSARY, VAGINAL

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 50 Millimeter
Width: 40 Millimeter

Device Record Status

Public Device Record Key: a2b6f346-5a7d-4515-a804-5964a60a9c32
Public Version Date: January 08, 2025
Public Version Number: 3
DI Record Publish Date: January 19, 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)340-3102
Email: xxx@xxx.xxx

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