FDA UDI
In Commercial Distribution
🇺🇸 United States
Sitzmarks Radiopaque Markers
DI: 00610858081306
·
Model: Combo Pak
·
KONSYL PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Sitzmarks Radiopaque Markers
- Primary DI
- 00610858081306
- Version / Model
- Combo Pak
- Company Name
- KONSYL PHARMACEUTICALS, INC.
- Labeler DUNS
- 102463866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-06-22
- Public Version
- 2
- Public Version Date
- 2023-09-28
- Public Version Status
- Update
- Public Device Record Key
- f28c3aed-9703-4cdb-8c98-ffea9bc15861
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62385 | Gastrointestinal telemetric monitoring system capsule, ingestible | A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00610858081306 | GS1 | ||||
| Unit of Use | 30610858081130 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K881609 | 000 |