Identity
- Trade Name
- Spectra RTE Kit FDA UDI
- Generic Name
- Penile prosthesis extender FDA UDI
- Device Name
- Rear Tip Extender Kit 2 Each - 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm FDA UDI
- Model / Reference
- 720170-01 FDA UDI
- Description
- Rear Tip Extender Kit 2 Each - 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00878953005393 FDA UDI
- FDA Product Code
- FAE FDA UDI
- GMDN Term
- Penile prosthesis extender FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.3630 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 9.5 Millimeter FDA UDILength — 3.0 Centimeter FDA UDILength — 2.0 Centimeter FDA UDILength — 1.5 Centimeter FDA UDILength — 1.0 Centimeter FDA UDILength — 0.5 Centimeter FDA UDI
Spectra RTE Kit by American Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- American Medical Systems, Inc.
Sources (1)
- FDA UDI 8ec2f502-7a2e-472f-80ab-9d1e26e31bd5 35 fields · synced May 30, 2026