Epifilm Otologic 1417000

GUDID 08033549791018

Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

Anika Therapeutics, Inc.

Tympanic membrane prosthesis
Primary Device ID08033549791018
NIH Device Record Key7f0b7170-b363-4364-8120-c58be8a412a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpifilm Otologic
Version Model Number653-200
Catalog Number1417000
Company DUNS807613393
Company NameAnika Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool, dry place, T< or = 40 C

Device Identifiers

Device Issuing AgencyDevice ID
GS108033549790974 [Previous]
GS108033549791018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

On-Brand Devices [Epifilm Otologic]

08033549791018Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs an
08033549791063Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs an

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.