FDA UDI
In Commercial Distribution
🇺🇸 United States
EDWARDS INTUITY ELITE AORTIC SIZER 19
DI: 00690103200225
·
Model: 1183R
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EDWARDS INTUITY ELITE AORTIC SIZER 19
- Primary DI
- 00690103200225
- Version / Model
- 1183R
- Catalog Number
- 1183R19
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-06
- Public Version
- 1
- Public Version Date
- 2026-04-14
- Public Version Status
- New
- Public Device Record Key
- 76870a02-f1b4-457e-86a5-c0e2756de0c1
Device Description
Edwards Intuity Elite Valve System Aortic Sizer 19mm
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 |
|---|---|---|---|---|
| DTI | Sizer, Heart-Valve, Prosthesis | Cardiovascular | 870.3945 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47684 | Heart valve annulus sizer, reusable | A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103200225 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9837
- [email protected]