AESCULAP - LUIKART-SIMPSON Obstetrical Forceps, 14", (355 - AESCULAP, INC.

Duns Number:082594540

Device Description: LUIKART-SIMPSON Obstetrical Forceps, 14", (355 mm), non-sterile, reusable

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More Product Details

Catalog Number

MB298R

Brand Name

AESCULAP

Version/Model Number

MB298R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2021

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

HDA

Product Code Name

Forceps, obstetrical

Device Record Status

Public Device Record Key

b9688530-6080-46ac-9a96-c4f1faa2e9a9

Public Version Date

June 23, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

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