Identity
- Trade Name
- BOOST FDA UDI
- Generic Name
- Freestanding headrest, single-use FDA UDI
- Device Name
- The Boost head positioner helps to stabilize a patient's head during ERCP and other gastrointestinal endoscopy procedures. FDA UDI
- Model / Reference
- 00711654 FDA UDI
- Description
- The Boost head positioner helps to stabilize a patient's head during ERCP and other gastrointestinal endoscopy procedures. FDA UDI
Identifiers
- Catalog Number
- 00711654 FDA UDI
- Primary DI / UDI-DI
- 00724995184056 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Freestanding headrest, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDI
Category: Freestanding headrest, single-use
Boost by US Endoscopy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding headrest, single-use.
- PRON HEADREST — BIRD & CRONIN, LLC · Class I
- PILLOW, GENTLETOUCH 6 INCH RT — Mizuho Orthopedic Systems, Inc. · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- HEADREST, 9" DONUT — Mizuho Orthopedic Systems, Inc. · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI cf07d42b-bb29-410b-9024-1d4e6823fe70 37 fields · synced May 29, 2026