ATRAMAT - ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 5-0 EP - Internacional Farmacéutica, S.A. de C.V.

Duns Number:811313428

Device Description: ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 5-0 EP 1, 45 CM NEEDLE HPE-13 ATRAGLIDE CUTTING ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 5-0 EP 1, 45 CM NEEDLE HPE-13 ATRAGLIDE CUTTING 13 MM 3/8 CIRCLEPGLA90 INCOLORO USP 5-0, 45 CM AGUJA HPE-13 CORTANTE ATRAGLIDE 13 MM 3/8 CIRCULO

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More Product Details

Catalog Number

HPE13305-45B

Brand Name

ATRAMAT

Version/Model Number

PGLA90

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

K072863,K072863

Product Code Details

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Record Status

Public Device Record Key

140dfcd3-6acd-4b3e-8012-1b801678b5a0

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 13, 2018

Additional Identifiers

Package DI Number

07500142157271

Quantity per Package

12

Contains DI Package

07500142057274

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