AccessGUDID - DEVICE: Integra® Miltex® (10381780171492)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 30-RK0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-RK0
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780171492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® PESSARY RING WITH KNOB SIZE 0 WITHOUT SUPPORT

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
34149	Pelvic-organ-supporting pessary	A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHW	PESSARY, VAGINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013289	000

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
Device Size Text, specify: Size 0 (1.75" OD)

Device Record Status

Public Device Record Key: c03003b8-2cfc-42ea-9cff-6c9b600b6729
Public Version Date: December 20, 2024
Public Version Number: 9
DI Record Publish Date: August 26, 2016