FDA UDI
In Commercial Distribution
🇺🇸 United States
Guerbet
DI: 06938327906191
·
Model: 200103-AF
·
Shenzhen Boon Medical Supply Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Guerbet
- Primary DI
- 06938327906191
- Version / Model
- 200103-AF
- Catalog Number
- 247238
- Company Name
- Shenzhen Boon Medical Supply Co., Ltd.
- Labeler DUNS
- 529174252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-17
- Public Version
- 2
- Public Version Date
- 2025-06-24
- Public Version Status
- Update
- Public Device Record Key
- 19c530ee-e4cc-439e-a774-62e4f44a9129
- Distribution End Date
- 9999-12-31
Device Description
OPTIS SU 2XSYR60ML Y-COIL150CM S X50 Optistar Elite®Dual MR syringe with Single Check Valve Y Tubing (90"/2300mm) and filling spikes - 60mL
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
- No
- 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 |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16545 | Angiography kit | A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26938327906195 | GS1 | carton | 50 | In Commercial Distribution | 9999-12-31 |
| Primary | 06938327906191 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]