Identity
- Trade Name
- Cradles EUDAMEDFDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Cradles EUDAMEDNeedle Localization Wire Protectors FDA UDI
- Model / Reference
- 309S EUDAMEDFDA UDI
- Description
- Needle Localization Wire Protectors FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815137020220 EUDAMED00815137021602 FDA UDI
- Basic UDI-DI
- 00815137021602BH EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Medical Purpose
- Needle Localization Wire Protectors EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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: Hypodermic needle, single-use
Cradles by Beekley Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00815137021602BH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-PR-000044332
Sources (2)
- EUDAMED 23fa31e7-a627-4fb5-917d-c37425bc60fd 61 fields · synced Jul 9, 2026
- FDA UDI e0284ec1-b49f-4bc1-abd2-bb464af8290f 33 fields · synced May 30, 2026