FDA UDI
In Commercial Distribution
🇺🇸 United States
GRAFT SIZERS
DI: 00384401016502
·
Model: Size 05 mm - 24 mm
·
INTERVASCULAR SAS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GRAFT SIZERS
- Primary DI
- 00384401016502
- Version / Model
- Size 05 mm - 24 mm
- Company Name
- INTERVASCULAR SAS
- Labeler DUNS
- 382174019
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 1c086bcf-5c67-43aa-a791-dd5f1cfa9217
Device Description
Graft Sizers size 05 mm - 24 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200201.
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Cardiovascular | 870.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44744 | Open-surgery blood vessel sizer, single-use | A sterile, invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00384401513032 | GS1 | Multipack Box of 10 | 10 | In Commercial Distribution | |
| Primary | 00384401016502 | GS1 |
Customer Contacts
- Phone
- +33442084646
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854431 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 05 mm - 24 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at controlled room temperature