Identity
- Trade Name
- PEMF - PHYSIO-STIM FDA UDI
- Generic Name
- Flexible video laryngoscope FDA UDI
- Device Name
- 5315CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE FDA UDI
- Model / Reference
- 655315-0003 FDA UDI
- Description
- 5315CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE FDA UDI
Identifiers
- Catalog Number
- 5315CE FDA UDI
- Primary DI / UDI-DI
- 18257200135707 FDA UDI
- PMA Number
- P850007 FDA UDI
- FDA Product Code
- LOF FDA UDI
- GMDN Term
- Flexible video laryngoscope FDA UDI
Classification
- Device Class
- Class III 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
Category: Flexible video laryngoscope
Pemf - Physio-Stim by Orthofix US LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video laryngoscope.
- RHINO-LARYNGO VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- SourceMark — SOURCEMARK, LLC. · Class I
- VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class II
- SourceMark — SOURCEMARK, LLC. · Class I
- VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class II
- SourceMark — SOURCEMARK, LLC. · Class I
- SourceMark — SOURCEMARK, LLC. · Class I
Cleared under the same submission
P850007 also covers:
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US 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 III | Pending data |
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Manufacturer
- Manufacturer
- Orthofix US LLC
Sources (1)
- FDA UDI 289b26be-56ed-4211-a6c6-2eb0bffa785c 36 fields · synced May 30, 2026