ATRAMAT - ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 5-0 EP - Internacional Farmacéutica, S.A. de C.V.

Duns Number:811313428

Device Description: ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 5-0 EP 1,5, 75 CM NEEDLE CE-19 REVERSE CUTTING 19 ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 5-0 EP 1,5, 75 CM NEEDLE CE-19 REVERSE CUTTING 19 MM 3/8 CIRCLE

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More Product Details

Catalog Number

CE1915-75

Brand Name

ATRAMAT

Version/Model Number

CHROMIC GUT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2040

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

K911354,K911354

Product Code Details

Product Code

GAL

Product Code Name

Suture, Absorbable, Natural

Device Record Status

Public Device Record Key

b0bd805c-27ba-4305-9f4c-6e0d5fb62dbf

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Additional Identifiers

Package DI Number

07500142106422

Quantity per Package

12

Contains DI Package

07500142006425

Package Discontinue Date

December 31, 2040

Package Status

In Commercial Distribution

Package Type

DOZEN

"INTERNACIONAL FARMACÉUTICA, S.A. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
2 A medical device with a moderate to high risk that requires special controls. 830