Integra® Miltex® - PESSARY SHAATZ, SIZE 8 - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: PESSARY SHAATZ, SIZE 8

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More Product Details

Catalog Number

30-SH8

Brand Name

Integra® Miltex®

Version/Model Number

30SH8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092981

Product Code Details

Product Code

HHW

Product Code Name

PESSARY, VAGINAL

Device Record Status

Public Device Record Key

aefb124c-c103-4040-80bb-e44173e05b23

Public Version Date

December 06, 2021

Public Version Number

6

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES PRODUCTION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15051
2 A medical device with a moderate to high risk that requires special controls. 4286
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3