RELI® - REDISORB PRO VIO BR 3-0 YFS-1 18" - MYCO MEDICAL SUPPLIES INC.

Duns Number:879187821

Device Description: REDISORB PRO VIO BR 3-0 YFS-1 18"

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More Product Details

Catalog Number

V442-M

Brand Name

RELI®

Version/Model Number

V442-M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172659,K172659,K172659

Product Code Details

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Record Status

Public Device Record Key

7066da71-70cb-4534-8183-a043ffa358e6

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Additional Identifiers

Package DI Number

10386120011759

Quantity per Package

12

Contains DI Package

00386120011752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton

"MYCO MEDICAL SUPPLIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 471