Puragraft - C6 3-0 Ch Gut 18"/45cm - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: C6 3-0 Ch Gut 18"/45cm

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More Product Details

Catalog Number

-

Brand Name

Puragraft

Version/Model Number

PGT525B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GAL

Product Code Name

SUTURE, ABSORBABLE, NATURAL

Device Record Status

Public Device Record Key

042feba9-8234-48e0-8bb4-66c26bfc867f

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

February 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGICAL SPECIALTIES MÉXICO, S. DE R.L. 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 300
2 A medical device with a moderate to high risk that requires special controls. 2030
U Unclassified 19