FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EpiDisc TM Perf Patch Kit
DI: 08033549790752
·
Model: 653-160
·
Anika Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EpiDisc TM Perf Patch Kit
- Primary DI
- 08033549790752
- Version / Model
- 653-160
- Catalog Number
- 1417151
- Company Name
- Anika Therapeutics, Inc.
- Labeler DUNS
- 807613393
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-19
- Public Version
- 4
- Public Version Date
- 2025-06-12
- Public Version Status
- Update
- Public Device Record Key
- 978152c1-15cd-4288-9947-5876e0aac3e3
- Distribution End Date
- 2025-06-11
Device Description
EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033549790752 | GS1 |