AESCULAP - S4 ELEMENT 7.0-8.0 EXTENDED SCREW CADDY - AESCULAP, INC.

Duns Number:082594540

Device Description: S4 ELEMENT 7.0-8.0 EXTENDED SCREW CADDY

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More Product Details

Catalog Number

MF997

Brand Name

AESCULAP

Version/Model Number

MF997

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

1246b691-6e39-4689-a43a-123359bc1b9d

Public Version Date

November 11, 2021

Public Version Number

2

DI Record Publish Date

June 29, 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