AESCULAP - GRUBER SPECULUM OVAL END SZ2 2.4X3.2 34MM - AESCULAP, INC.

Duns Number:082594540

Device Description: GRUBER SPECULUM OVAL END SZ2 2.4X3.2 34MM

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More Product Details

Catalog Number

MA120R

Brand Name

AESCULAP

Version/Model Number

MA120R

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

EPY

Product Code Name

SPECULUM, ENT

Device Record Status

Public Device Record Key

948a18f7-8f20-4676-893e-90d0c04ef61a

Public Version Date

June 24, 2022

Public Version Number

3

DI Record Publish Date

May 08, 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