Identity
- Trade Name
- CORE FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- Aria Drill FDA UDI
- Model / Reference
- 5400210000 FDA UDI
- Description
- Aria Drill FDA UDI
Identifiers
- Catalog Number
- 5400-210-000 FDA UDI
- Primary DI / UDI-DI
- 07613154499991 FDA UDI
- FDA Product Code
- HBB FDA UDI
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone/joint surgical power tool motorized handpiece/set, pneumatic
Core by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone/joint surgical power tool motorized handpiece/set, pneumatic.
- LEOPARD — IMEDICOM CO., LTD. · Class I
- LEOPARD — IMEDICOM CO., LTD. · Class I
- ELAN 4 — AESCULAP, INC. · Class II
- ELAN 4 — AESCULAP, INC. · Class II
- ELAN 4 — AESCULAP, INC. · Class II
- ELAN 4 — AESCULAP, INC. · Class II
- ELAN 4 — AESCULAP, INC. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 05e9d14b-d3c2-4418-818d-d8d268660233 36 fields · synced Jun 8, 2026