Identity
- Trade Name
- HemaClear FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- All in One Surgical Tourniquet for Limb Surgery FDA UDI
- Model / Reference
- Green Sterile Single Unit FDA UDI
- Description
- All in One Surgical Tourniquet for Limb Surgery FDA UDI
Identifiers
- Catalog Number
- SAH040-GR-01A FDA UDI
- Primary DI / UDI-DI
- 07290012685224 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Tourniquet cuff, single-use 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
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
Category: Tourniquet cuff, single-use
HemaClear by Oneg Hakarmel Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, single-use.
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- Sterile Disposable Contour Cuff — Delfi Medical Innovations Inc · Class I
- Tourniquet cuff — NINGBO ZHUOQIU MEDICAL EQUIPMENT CO., LTD. · Class I
- Pneumatic Tourniquet Cuff — Tiantai Typhung Medical Supplies Co., Ltd · Class I
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- TMT Rigid Holster Kit w/ Malice Clip Tactical Taylor Back Attachment — SAFEGUARD US OPERATING, LLC · Class I
- Mobile Stand for Tourniquet — VBM Medizintechnik GmbH · 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
- Oneg Hakarmel Ltd
Sources (1)
- FDA UDI a1f14d0e-cae9-48f9-bce5-50e816323f59 34 fields · synced May 30, 2026