AccessGUDID - DEVICE: Epifilm Otologic (08033549791063)

GUDID

Device Identifier (DI) Information

Brand Name: Epifilm Otologic
Version or Model: 653-200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1417000
Company Name: Anika Therapeutics, Inc.

Primary DI Number: 08033549791063
Issuing Agency: GS1
Commercial Distribution End Date: June 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 807613393 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34410	Tympanic membrane prosthesis	A device intended for the repair or replacement of the membrana tympani of the middle ear typically implanted during ear/nose/throat (ENT) surgery. It is made of synthetic polymer material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: store in a cool, dry place, T< or = 40 C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92778f9a-6f66-46e6-be4c-742351502168
Public Version Date: June 12, 2025
Public Version Number: 2
DI Record Publish Date: February 04, 2022