Identity
- Trade Name
- Ballspike, Straight, L=200mm FDA UDI
- Generic Name
- Orthopaedic ball spike FDA UDI
- Model / Reference
- 64012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120115620021 FDA UDI
- FDA Product Code
- HTD FDA UDI
- GMDN Term
- Orthopaedic ball spike FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic ball spike
Ballspike, Straight, L=200mm by I.T.S. GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic ball spike.
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- SMR Shoulder — Limacorporate · Class II
- SMR Shoulder — Limacorporate · Class II
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- SMR Shoulder — Limacorporate · Class II
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 |
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Manufacturer
- Manufacturer
- I.T.S. GmbH
Sources (1)
- FDA UDI cb0ef9e9-8c1c-42ff-b36d-aa6d8a9fc43a 32 fields · synced Jun 8, 2026