Identity
- Trade Name
- Manus Medical, LLC FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, single-use FDA UDI
- Device Name
- Peripheral Triple Ctrscp FDA UDI
- Model / Reference
- SEPA 403-CTRSCP-1 FDA UDI
- Description
- Peripheral Triple Ctrscp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811870037795 FDA UDI
- FDA Product Code
- LWX FDA UDI
- GMDN Term
- Patient radiation shielding pad/drape, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Patient radiation shielding pad/drape, single-use
Manus Medical, LLC by Manus Medical, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Halyard Scatter Radiation Shields — ANGIOSYSTEMS, INCORPORATED · 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 III | Pending data |
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Manufacturer
- Manufacturer
- Manus Medical, LLC
Sources (1)
- FDA UDI 66bd8493-5eb8-49c0-85cd-8cd1da254f46 33 fields · synced May 31, 2026