Epidisc 2pk Otologic 8mm - EpiDisc Otologic Lamina is used as an implant - Anika Therapeutics, Inc.

Duns Number:807613393

Device Description: EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as a EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

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More Product Details

Catalog Number

1417100

Brand Name

Epidisc 2pk Otologic 8mm

Version/Model Number

653-300

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K982870

Product Code Details

Product Code

KHJ

Product Code Name

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Device Record Status

Public Device Record Key

04de76e9-48bc-4068-affd-1c03bc9c22f3

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANIKA THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 15
3 A medical device with high risk that requires premarket approval 15