Identity
- Trade Name
- Syringe, 10 mL FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. FDA UDI
- Model / Reference
- E01P3 FDA UDI
- Description
- The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. FDA UDI
Identifiers
- Catalog Number
- E01P3 FDA UDI
- Primary DI / UDI-DI
- 16286780610023 FDA UDI
- 510(k) Number
- K201652 FDA UDI
- FDA Product Code
- MJN FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Syringe, 10 mL by Front Line Medical Technologies Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Front Line Medical Technologies Inc.
Sources (2)
- FDA UDI 4d2e4516-796e-435e-9a7f-10a53ece5bfa 37 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026