FSSB - 2xDDSL-6.4-150 USP 8-0 Polypropylene blue 36x45 - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: 2xDDSL-6.4-150 USP 8-0 Polypropylene blue 36x45 cm. sterile VA10

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More Product Details

Catalog Number

H001PP3

Brand Name

FSSB

Version/Model Number

H001PP3

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

K131224,K131224

Product Code Details

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Device Record Status

Public Device Record Key

56dfc06d-d653-41c2-8593-8afba40ddc8f

Public Version Date

August 29, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

10848782042729

Quantity per Package

36

Contains DI Package

00848782042722

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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