Identity
- Trade Name
- Micro Seal Shell FDA UDI
- Generic Name
- Metallic acetabular liner FDA UDI
- Device Name
- Micro Seal Shell 52mm FDA UDI
- Model / Reference
- 52mm FDA UDI
- Description
- Micro Seal Shell 52mm FDA UDI
Identifiers
- Catalog Number
- WA-1-1025 FDA UDI
- Primary DI / UDI-DI
- B046WA110250 FDA UDI
- 510(k) Number
- K971718 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Metallic acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metallic acetabular liner
Micro Seal Shell by Signal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K971718 also covers:
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
- Micro Seal Shell — Signal Medical Corp.
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
- Signal Medical Corp.
Sources (1)
- FDA UDI 9097b636-f4e8-457d-a250-455b69f5189e 36 fields · synced Jun 1, 2026