Identity
- Trade Name
- ASSI FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Breast Reduction Compression Device Extra Large tourniquet, for approx. 1300gm reduction 5/SET STERILE FDA UDI
- Model / Reference
- ASSI.BRC5XL FDA UDI
- Description
- Breast Reduction Compression Device Extra Large tourniquet, for approx. 1300gm reduction 5/SET STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841645117407 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Tourniquet cuff, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5900 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tourniquet cuff, reusable
Assi by Accurate Surgical & Scientific Instruments Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, reusable.
- Color Cuff — Stryker Corp. · Class I
- Vari-Fit Reusable — Delfi Medical Innovations Inc · Class I
- Reusable Conical Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Easi-Fit BFR, Reusable — Delfi Medical Innovations Inc · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Vari-Fit Reusable — Delfi Medical Innovations Inc · Class I
- Easi-Fit Reusable — Delfi Medical Innovations 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
- Accurate Surgical & Scientific Instruments Corp.
Sources (1)
- FDA UDI 52c478ef-9896-402a-b2c2-8f3e494f997a 33 fields · synced May 31, 2026