FDA UDI
In Commercial Distribution
🇺🇸 United States
Visura TEECAD Carrier
DI: 00860226002529
·
Model: CR-P2
·
VISURA TECHNOLOGIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Visura TEECAD Carrier
- Primary DI
- 00860226002529
- Version / Model
- CR-P2
- Catalog Number
- VIS0100
- Company Name
- VISURA TECHNOLOGIES, INC.
- Labeler DUNS
- 117057841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-26
- Public Version
- 1
- Public Version Date
- 2022-08-03
- Public Version Status
- New
- Public Device Record Key
- a8037668-3775-4f3f-baf7-2fb5bf58d451
Device Description
Visura TEECAD Carrier
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40786 | Ultrasound imaging transducer positioning unit | A unit used to position an ultrasound system imaging transducer that is inserted into the body through an endoscope. This device is an accessory to a diagnostic ultrasound imaging system and it transmits electrical signals that, after processing, will display the position of a the transducer on a monitor. This unit will assist the endoscopist in the placement of the working transducer (the probe) and to allow monitoring of the movement after placement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860226002529 | GS1 | ||||
| Previous | 00860226002505 | GS1 |
Customer Contacts
- Phone
- (651) 236-9226
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180911 | 000 |