AESCULAP - PROSPACE BONE ALIF RING CURETTE STR - AESCULAP IMPLANT SYSTEMS, LLC

Duns Number:622600992

Device Description: PROSPACE BONE ALIF RING CURETTE STR

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More Product Details

Catalog Number

ME468

Brand Name

AESCULAP

Version/Model Number

ME468

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)

Yes

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

c6489802-dc87-492b-9e88-c4b3a577a19a

Public Version Date

July 13, 2020

Public Version Number

1

DI Record Publish Date

July 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP IMPLANT SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 200
2 A medical device with a moderate to high risk that requires special controls. 54