FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sonata® IUUS Probe Soaking Cylinder
DI: 10817929020142
·
Model: CYL-001
·
GYNESONICS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sonata® IUUS Probe Soaking Cylinder
- Primary DI
- 10817929020142
- Version / Model
- CYL-001
- Catalog Number
- CYL-001
- Company Name
- GYNESONICS, INC.
- Labeler DUNS
- 618493741
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 3
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- e7c4baa1-a346-40ce-b1b2-e12b21bf68ab
- Distribution End Date
- 2020-09-03
Device Description
General laboratory container, reusable
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Obstetrics/Gynecology | 884.4160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35413 | General laboratory container, reusable | A container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), biological specimens, and other materials associated with in the laboratory; it is not intended for in vitro diagnostic procedures. It is designed to withstand an extremely high-temperature environment (e.g., autoclaving) to enable repeated sterilization. It is typically made of high-temperature-resistant plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers (e.g., tissue culture). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817929020142 | GS1 |
Customer Contacts
- Phone
- 650-216-3860
- [email protected]