FDA UDI
In Commercial Distribution
🇺🇸 United States
VALVEVAULT™
DI: 00850012846086
·
Model: 081040
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VALVEVAULT™
- Primary DI
- 00850012846086
- Version / Model
- 081040
- Catalog Number
- 081040
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 2
- Public Version Date
- 2023-11-20
- Public Version Status
- Update
- Public Device Record Key
- 916439cb-025e-40d5-9816-1c7c94f55632
Device Description
VALVEVAULT™ DEVICE KIT This kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVICE (S), (M), (L), all of which have Direct Marking.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31707 | Heart valve prosthesis holder, reusable | A hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012846086 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | (S) Chambers - Diameter: 19, 21 mm; Depth: 11.5, 12.5 mm (M) Chambers - Diameter: 23, 25 mm; Depth: 13.5, 14.5 mm (L) Chambers - Diameter: 27, 29 mm; Depth: 15.5, 16.2 mm |