FDA UDI
In Commercial Distribution
🇺🇸 United States
HEART VALVE ACCESSOR
DI: 00690103019339
·
Model: 1150
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HEART VALVE ACCESSOR
- Primary DI
- 00690103019339
- Version / Model
- 1150
- Catalog Number
- 1150
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-18
- Public Version
- 1
- Public Version Date
- 2024-10-28
- Public Version Status
- New
- Public Device Record Key
- f8d6c8d0-5e82-4f3e-a97f-94070712f6a4
Device Description
HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
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 |
|---|---|---|---|---|
| DTJ | Holder, Heart-Valve, Prosthesis | Cardiovascular | 870.3935 | 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 | 00690103019339 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry, cool place