Identity
- Trade Name
- Sitzmarks Radiopaque Markers FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
- Model / Reference
- Double D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610858081085 FDA UDI
- 510(k) Number
- K881609 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Gastrointestinal telemetric monitoring system capsule, ingestible
Sitzmarks Radiopaque Markers by Konsyl Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastrointestinal telemetric monitoring system capsule, ingestible.
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Cleared under the same submission
K881609 also covers:
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC.
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
- Konsyl Pharmaceuticals, Inc.
Sources (1)
- FDA UDI d985e487-7a91-4d9a-a345-46efd6d16b28 33 fields · synced Jun 8, 2026