Identity
- Trade Name
- Epiphany FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Device Name
- Fraizer Suction Tube 12 FR FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Fraizer Suction Tube 12 FR FDA UDI
Identifiers
- Catalog Number
- 1018-1201 FDA UDI
- Primary DI / UDI-DI
- B28101812010 FDA UDI
- 510(k) Number
- K113781 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use 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
Yes
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
Category: Surgical/emergency suction cannula, non-illuminating, single-use
Epiphany by Pantheon Spinal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, single-use.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- Argyle — Cardinal Health 200, LLC · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- NETWORK — Network Medical Products, Ltd. · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- BR Surgical, LLC — BR SURGICAL LLC · 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 ba48df8c-7ddf-4e4d-9a46-3bd89adcf55e 36 fields · synced Jun 8, 2026