Sklar - COLIBRI FCP NOTCHED 4 IN CS/10 - SKLAR CORPORATION

Duns Number:006966006

Device Description: COLIBRI FCP NOTCHED 4 IN CS/10

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More Product Details

Catalog Number

-

Brand Name

Sklar

Version/Model Number

96-3652

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

HNR

Product Code Name

Forceps, ophthalmic

Device Record Status

Public Device Record Key

0ae03a7e-981d-4d84-b9b6-4b3c55e20608

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

September 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKLAR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13420
2 A medical device with a moderate to high risk that requires special controls. 881