FDA UDI
In Commercial Distribution
🇺🇸 United States
AVR NAVIGATOR™
DI: 00850012846291
·
Model: 081446
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVR NAVIGATOR™
- Primary DI
- 00850012846291
- Version / Model
- 081446
- Catalog Number
- 081446
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-02
- Public Version
- 1
- Public Version Date
- 2024-02-12
- Public Version Status
- New
- Public Device Record Key
- c7931003-eb2f-4157-921d-f74d81e198e8
Device Description
AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64618 | Aortic root retraction system | An assembly of devices intended to be used during aortic valve replacement via aortotomy to facilitate temporary stabilization of the aortic root for improved aortic valve site exposure, visualization and tissue tension. It consists of a circular frame that is placed within the aortic ring, sutures and suture retaining loops, and a deployment device with handle and shaft; it may be used during minimally-invasive and open surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850012846298 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00850012846291 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 19 | Millimeter |