Identity
- Trade Name
- Tentacles FDA UDI
- Generic Name
- Hand-held surgical retractor, single-use FDA UDI
- Device Name
- This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by means of suction pressure applied to each one of them. Traction Tubes are pulled and clamped to the surgical drape by Forceps in order to fix the position of the heart. FDA UDI
- Model / Reference
- MD-27310 FDA UDI
- Description
- This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by means of suction pressure applied to each one of them. Traction Tubes are pulled and clamped to the surgical drape by Forceps in order to fix the position of the heart. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04545499071194 FDA UDI
- FDA Product Code
- MWS FDA UDI
- GMDN Term
- Hand-held surgical retractor, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held surgical retractor, single-use
Tentacles by Sb-Kawasumi Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hand-held surgical retractor, single-use.
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- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- SOAR Retractor System — SPINEOLOGY INC. · Class I
- SOAR Retractor System — SPINEOLOGY INC. · 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
- Sb-Kawasumi Laboratories, Inc.
Sources (1)
- FDA UDI 4ad059d7-4066-4d9c-af89-e738066e5aba 33 fields · synced May 30, 2026