SonoVision
- Primary DI
- 00860001239379
- Brand
- SonoVision
- Company
- Tissue Differentiation Intelligence LLC
- Model
- 100033
- Device description
- SonoVision Accessory Kit Initial Dilator
- Published
- 2022-12-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860001239379 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860001239379 | 00860001239379 | 860001239379 | 0860001239379 |
GMDN Terms#
| Term | Definition |
|---|---|
| Interventional radiology percutaneous-access kit, reusable | A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a reusable device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Fragile; handle with care |
| Special Storage Condition, Specify | 0 | 0 | Keep Dry |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| (305) 351-2011 | info@tissueintel.com |
Regulatory Flags#
- DUNS number
- 081327336
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00860001239324 | SonoVision | 100021 | 2022-12-08 | |
| 00860001239331 | SonoVision | 100022 | 2022-12-08 | |
| 00860001239362 | SonoVision | 100030 | 2022-12-08 | |
| 00860001239386 | SonoVision | 100034 | 2022-12-08 | |
| 00860001239300 | SonoVision | 100039 | 2022-11-03 | |
| 00860001239348 | Beluga1 | 100005 | 2022-03-03 | |
| 00860001239355 | SonoVision | 100009 | 2022-03-03 |
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|---|---|---|---|---|
| 00199150002139 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | LXH | 2026-07-16 |
| 00199150002146 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | LXH | 2026-07-16 |
| 00763000754730 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | LXH | 2026-07-16 |
| 00763000754747 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | LXH | 2026-07-16 |
| 00822409082124 | N/A | Ortho Development Corporation | LXH | 2026-07-16 |
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| 00840606188135 | Ventana A | SPINAL ELEMENTS, INC. | LXH | 2026-07-16 |
| 00840606188142 | Ventana A | SPINAL ELEMENTS, INC. | LXH | 2026-07-16 |
| 00840606188159 | Ventana A | SPINAL ELEMENTS, INC. | LXH | 2026-07-16 |