ATRAMAT - ATRAMAT SILK SURGICAL SUTURE BLACK USP 5 EP 7, 75 - Internacional Farmacéutica, S.A. de C.V.

Duns Number:811313428

Device Description: ATRAMAT SILK SURGICAL SUTURE BLACK USP 5 EP 7, 75 CM DOUBLE NEEDLE PE-75 PREMIUM REVERSE C ATRAMAT SILK SURGICAL SUTURE BLACK USP 5 EP 7, 75 CM DOUBLE NEEDLE PE-75 PREMIUM REVERSE CUTTING 75 MM 3/8 CIRCLESEDA NEGRA USP 5, 75 CM DOBLE AGUJA PE-75 REVERSO CORTANTE PREMIUM 75 MM 3/8 CIRCULO

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More Product Details

Catalog Number

PE75350/2-75

Brand Name

ATRAMAT

Version/Model Number

SEDA

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

K905287,K905287

Product Code Details

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Device Record Status

Public Device Record Key

d27aad3f-213e-4c27-880b-e198f38bb12d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 27, 2018

Additional Identifiers

Package DI Number

07500142180613

Quantity per Package

12

Contains DI Package

07500142080616

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