Identity
- Trade Name
- EPIPHANY FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Device Name
- 3MM X 12 IN ANGLE RT PITUITARY RONGEUR FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 3MM X 12 IN ANGLE RT PITUITARY RONGEUR FDA UDI
Identifiers
- Catalog Number
- 1016-0303 FDA UDI
- Primary DI / UDI-DI
- B528101603030 FDA UDI
- 510(k) Number
- K113781 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDIWidth — 3 Millimeter FDA UDI
Category: Orthopaedic joint/limb rongeur
Epiphany by Pantheon Spinal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic joint/limb rongeur.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Sklar® — Sklar Corporation · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- MICRO FRIEDMAN RONGEUR — SONTEC INSTRUMENTS, INC. · Class I
- Sklar® — Sklar Corporation · Class I
Cleared under the same submission
K113781 also covers:
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pantheon Spinal LLC
Sources (1)
- FDA UDI 7ca2fd44-9a50-4db2-bfdc-5576115a0435 37 fields · synced May 30, 2026