Identity
- Trade Name
- Smart SPACE SHOULDER FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- Smart SPACE SHOULDER - Humerus Anatomical Model-RIGHT3-NOT STER FDA UDI
- Model / Reference
- 0023.R3.N33.A FDA UDI
- Description
- Smart SPACE SHOULDER - Humerus Anatomical Model-RIGHT3-NOT STER FDA UDI
Identifiers
- Catalog Number
- 0023.R3.N33.A FDA UDI
- Primary DI / UDI-DI
- 08033390237017 FDA UDI
- 510(k) Number
- K222405 FDA UDI
- FDA Product Code
- QHE FDA UDIKWS FDA UDIMBF FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Custom-made organ/bone anatomy model
Smart SPACE SHOULDER by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222405 also covers:
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
- Smart SPACE SHOULDER — Limacorporate
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
- Limacorporate
Sources (1)
- FDA UDI b7b44694-bb51-451f-8f26-07d6f3191296 35 fields · synced May 30, 2026