IMCO - Polypropylene Suture, 4-0, C3 Needle - INDEPENDENT MEDICAL CO-OP, INC.

Duns Number:073436164

Device Description: Polypropylene Suture, 4-0, C3 Needle

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More Product Details

Catalog Number

-

Brand Name

IMCO

Version/Model Number

8699-IMC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Device Record Status

Public Device Record Key

f1a84288-9fe5-4d4a-b22b-e243808c9016

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

June 13, 2016

Additional Identifiers

Package DI Number

10815842021574

Quantity per Package

12

Contains DI Package

00815842021577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"INDEPENDENT MEDICAL CO-OP, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 42