MeroGel Otologic Packing 1x5cm - MeroGel Otologic Packing is a space occupying - Anika Therapeutics, Inc.

Duns Number:807613393

Device Description: MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate m MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding and act as an adjunct to aid in the natural healing process.

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More Product Details

Catalog Number

1517100

Brand Name

MeroGel Otologic Packing 1x5cm

Version/Model Number

651-142

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

K001148,K001148

Product Code Details

Product Code

KHJ

Product Code Name

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

Device Record Status

Public Device Record Key

6f371715-4764-4ad6-92db-84cbbe8991a5

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

January 15, 2020

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