FUMEDICA - 2xHRS-26-680P USP 0 Polyester 90 cm with Pledgets - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: 2xHRS-26-680P USP 0 Polyester 90 cm with Pledgets 3x6mm. sterile. 10pcs. x (2 green + 2 wh 2xHRS-26-680P USP 0 Polyester 90 cm with Pledgets 3x6mm. sterile. 10pcs. x (2 green + 2 white)/ Box VA14.2

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More Product Details

Catalog Number

H26-0924N

Brand Name

FUMEDICA

Version/Model Number

H26-0924N

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

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Device Record Status

Public Device Record Key

e0282a8f-0d95-4723-97e2-ac6dd37ea5c2

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

10848782042071

Quantity per Package

10

Contains DI Package

00848782042074

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