ProCinch, Slotted Button, Concave Round 14mm - T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Duns Number:534123013

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More Product Details

Catalog Number

141200st

Brand Name

ProCinch, Slotted Button, Concave Round 14mm

Version/Model Number

234-100-002

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Device Record Status

Public Device Record Key

faf91ca5-8629-44dc-b04e-b8539cf5aca1

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 738
2 A medical device with a moderate to high risk that requires special controls. 351