Identity
- Trade Name
- SYNTH™ BES FDA UDI
- Generic Name
- Inflatable bone tamp FDA UDI
- Device Name
- NOT USE FDA UDI
- Model / Reference
- SYNTH BES20 FDA UDI
- Description
- NOT USE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038056169 FDA UDI
- 510(k) Number
- K153296 FDA UDI
- FDA Product Code
- NDN FDA UDIHRX FDA UDI
- GMDN Term
- Inflatable bone tamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.1100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Synth™ Bes by Imedicom Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K153296 also covers:
- B-Two Inflatable bone expander system balloon catheter — IMEDICOM CO., LTD.
- B-Two Inflatable bone expander system balloon catheter — IMEDICOM CO., LTD.
- B-Two Inflatable bone expander system balloon catheter — IMEDICOM CO., LTD.
- B-Two Inflatable bone expander system syringe — IMEDICOM CO., LTD.
- B-Two Vertebral Balloon Expand® Kyphoplasty System — IMEDICOM CO., LTD.
- B-Two Vertebral Balloon Expand® Kyphoplasty System — IMEDICOM CO., LTD.
- B-Two Vertebral Balloon Expand® Kyphoplasty System — IMEDICOM CO., LTD.
- B-Two Vertebral access system — IMEDICOM CO., LTD.
- MEDINAUT Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Kyphoplasty System — IMEDICOM CO., LTD.
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 |
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Manufacturer
- Manufacturer
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI aea7f02b-5887-4568-8fcc-0768cdaecdb8 35 fields · synced Jun 8, 2026