AESCULAP - RECIP.SAW BLADE 75/10/0.7/0.9MM STERILE - Aesculap AG

Duns Number:315018218

Device Description: RECIP.SAW BLADE 75/10/0.7/0.9MM STERILE

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More Product Details

Catalog Number

GC768R

Brand Name

AESCULAP

Version/Model Number

GC768R

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

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Device Record Status

Public Device Record Key

63b2db02-9334-4821-9816-cc79ff6dbba1

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

April 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11840
2 A medical device with a moderate to high risk that requires special controls. 7088
3 A medical device with high risk that requires premarket approval 37