Identity
- Trade Name
- SMR STEMLESS FDA UDI
- Generic Name
- Humeral head spacer FDA UDI
- Device Name
- SMR STEMLESS - 4MM ECCENTRICAL ADAPTOR WITH SCREW FDA UDI
- Model / Reference
- 1335.15.204 FDA UDI
- Description
- SMR STEMLESS - 4MM ECCENTRICAL ADAPTOR WITH SCREW FDA UDI
Identifiers
- Catalog Number
- 1335.15.204 FDA UDI
- Primary DI / UDI-DI
- 08033390107778 FDA UDI
- FDA Product Code
- PKC FDA UDI
- GMDN Term
- Humeral head spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Category: Humeral head spacer
Smr Stemless by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humeral head spacer.
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- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI 879d9258-50fe-45b5-800e-a5ae522919ef 35 fields · synced May 30, 2026