Identity
- Trade Name
- BE-ST NIM XPAK Needle Blunt FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Pedicle Access Kit Needle with Neural Integrity Monitor FDA UDI
- Model / Reference
- PK1010 FDA UDI
- Description
- Pedicle Access Kit Needle with Neural Integrity Monitor FDA UDI
Identifiers
- Catalog Number
- PK1010 FDA UDI
- Primary DI / UDI-DI
- 00853508002317 FDA UDI
- FDA Product Code
- PDQ FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10.95 Inch FDA UDI
Category: Bone access cannula
BE-ST NIM XPAK Needle Blunt by Lacey Manufacturing Company Llc — 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
- Lacey Manufacturing Company Llc
Sources (1)
- FDA UDI 86115550-23b8-40cb-8a28-958d25c1bb27 36 fields · synced May 29, 2026