TripleCheck™ Pouch - SAFCO STERILIZATION POUCH 3.5 X 9 BULK - SAFCO DENTAL SUPPLY CO.

Duns Number:020417380

Device Description: SAFCO STERILIZATION POUCH 3.5 X 9 BULK

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More Product Details

Catalog Number

102-0189

Brand Name

TripleCheck™ Pouch

Version/Model Number

102-0189

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Device Record Status

Public Device Record Key

ba24f9c8-a9f6-472e-b2a6-f40cccf5001d

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFCO DENTAL SUPPLY CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 600
2 A medical device with a moderate to high risk that requires special controls. 23