Identity
- Trade Name
- SILS Port FDA UDI
- Generic Name
- Rigid optical rectoscope, single-use FDA UDI
- Device Name
- Flexible Port FDA UDI
- Model / Reference
- SILSPT12TA FDA UDI
- Description
- Flexible Port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521102774 FDA UDI
- 510(k) Number
- K103253 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid optical rectoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Rigid optical rectoscope, single-use
SILS Port by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical rectoscope, single-use.
- KOLPLAST — Kolplast CI SA · Class I
- KOLPLAST — Kolplast CI SA · Class I
- SILS Port — Covidien LP · Class II
Cleared under the same submission
K103253 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI b4209f55-f953-467f-8825-cc447e4dda0e 37 fields · synced May 30, 2026