Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months) FDA UDI
- Model / Reference
- G07698 FDA UDI
- Description
- Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months) FDA UDI
Identifiers
- Catalog Number
- C-SDIN-15.5-3.0-T45-AF FDA UDI
- Primary DI / UDI-DI
- 00827002076983 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraosseous infusion kit
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Cook Incorporated
Sources (1)
- FDA UDI 2a7e9666-aa87-41ad-93ec-d6e9cb844c16 36 fields · synced Jun 8, 2026