Integra® Miltex® - CryoSolutions Control Mechanism - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: CryoSolutions Control Mechanism

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More Product Details

Catalog Number

33521

Brand Name

Integra® Miltex®

Version/Model Number

33521

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

K091721

Product Code Details

Product Code

GEH

Product Code Name

UNIT, CRYOSURGICAL, ACCESSORIES

Device Record Status

Public Device Record Key

ab711c7c-6065-4cc7-a899-dd6d0c4a1cce

Public Version Date

July 01, 2021

Public Version Number

6

DI Record Publish Date

August 16, 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