ATRAMAT - ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 6-0 EP - Internacional Farmacéutica, S.A. de C.V.

Duns Number:811313428

Device Description: ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-13 SUPRA-SHARP REV ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-13 SUPRA-SHARP REVERSE CUTTING 13 MM 3/8 CIRCLEPGLA90 INCOLORO USP 6-0, 45 CM AGUJA P-PE-13 REVERSO CORTANTE SUPRA-SHARP 13 MM 3/8 CIRCULO

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

P-PE13306-45B

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

cabe6335-178f-4af4-8483-7f4a56489023

Public Version Date

August 17, 2018

Public Version Number

1

DI Record Publish Date

July 17, 2018

Additional Identifiers

Package DI Number

07500142155659

Quantity per Package

12

Contains DI Package

07500142055652

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