RELI - REDILON Monofilament Polyamide (Nylon), Black, - MYCO MEDICAL SUPPLIES INC.

Duns Number:879187821

Device Description: REDILON Monofilament Polyamide (Nylon), Black, 3-0, MPS-1

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More Product Details

Catalog Number

-

Brand Name

RELI

Version/Model Number

N1663-SI

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Device Record Status

Public Device Record Key

42ded20d-29c7-4a43-b4be-3d6b94e14d55

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

20386120006035

Quantity per Package

30

Contains DI Package

10386120006038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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