Identity
- Trade Name
- BEST PAK Access Needle FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Pedicle Access Needle PAK Bevel/Bevel FDA UDI
- Model / Reference
- PK1001 FDA UDI
- Description
- Pedicle Access Needle PAK Bevel/Bevel FDA UDI
Identifiers
- Catalog Number
- PK1001 FDA UDI
- Primary DI / UDI-DI
- 00853508002218 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Bone access cannula
BEST PAK Access Needle by Lacey Manufacturing Company Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone access cannula.
- BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — Tecres · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Stryker — Provision · Class I
- Omnia Medical PsiF — Omnia Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Omnia Medical Instruments — Omnia Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Access Needle — INTERVENTIONAL SPINE, INC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lacey Manufacturing Company Llc
Sources (1)
- FDA UDI 269a34d4-13c0-4907-8887-ea5acd60ec87 35 fields · synced May 30, 2026