DEVICE: Integra® Miltex® (10381780171652)
Device Identifier (DI) Information
Integra® Miltex®
30-RS0
In Commercial Distribution
30-RS0
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RS0
In Commercial Distribution
30-RS0
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Integra® Miltex® PESSARY RING SIZE 0 WITH SUPPORT
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 [?] |
---|---|
K092981 | 000 |
Sterilization
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
3f06708c-a8b5-4155-9e58-1c9cb06f10e9
March 06, 2024
8
August 26, 2016
March 06, 2024
8
August 26, 2016
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 |
---|---|
HIBCC | H83430RS01 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com