AESCULAP - MICRO INSTRUMENT TRAY 250X380MM - AESCULAP, INC.

Duns Number:082594540

Device Description: MICRO INSTRUMENT TRAY 250X380MM

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More Product Details

Catalog Number

US953

Brand Name

AESCULAP

Version/Model Number

US953

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

73328986-02da-4693-8abf-a0c0a1542e17

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

February 08, 2021

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