AESCULAP - STRINGER CLOSED W/LOCK 300 X65MM - AESCULAP, INC.

Duns Number:082594540

Device Description: STRINGER CLOSED W/LOCK 300 X65MM

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More Product Details

Catalog Number

US890

Brand Name

AESCULAP

Version/Model Number

US890

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

5deeb344-3bea-4bac-900c-1c8ebb23a32c

Public Version Date

May 28, 2021

Public Version Number

2

DI Record Publish Date

August 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3239
2 A medical device with a moderate to high risk that requires special controls. 683