ATRAMAT - ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP - Internacional Farmacéutica, S.A. de C.V.

Duns Number:811313428

Device Description: ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM NEEDLE P-PE-19 SUPRA-SHARP REVERS ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM NEEDLE P-PE-19 SUPRA-SHARP REVERSE CUTTING 19 MM 3/8 CIRCLESEDA NEGRA USP 4-0, 45 CM AGUJA P-PE-19 REVERSO CORTANTE SUPRA-SHARP 19 MM 3/8 CIRCULO

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More Product Details

Catalog Number

P-PE1934-45

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"

Yes

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

d0cc6a5c-c5a8-40f1-9ac5-6f8b1be4698a

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 11, 2018

Additional Identifiers

Package DI Number

07500142157097

Quantity per Package

12

Contains DI Package

07500142057090

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