FDA UDI
In Commercial Distribution
🇺🇸 United States
Procedure Accessory Pack, 3.5F Coronary System, 5-Pack
DI: M097PAP00351
·
Model: PAP-0035
·
BEST VASCULAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Procedure Accessory Pack, 3.5F Coronary System, 5-Pack
- Primary DI
- M097PAP00351
- Version / Model
- PAP-0035
- Catalog Number
- PAP-0035
- Company Name
- BEST VASCULAR, INC.
- Labeler DUNS
- 789032039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 982a1ecf-b46d-4e70-9206-46fbee37e1fa
Device Description
Five Pack of Procedure Accessory Pack for 3.5F Coronary System
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 |
|---|---|---|---|---|
| MOU | Intravascular Radiation Delivery System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61711 | Manual-afterloading brachytherapy system source delivery procedure kit | A collection of sterile devices intended to dispense/collect hydraulic fluid used to deliver the radiation source train of a manual-afterloading brachytherapy system source transfer device to/from the delivery catheter/applicator. It consists of disposable devices such as syringes, fluid collection bags, adaptors/connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M097PAP00351 | HIBCC |
Customer Contacts
- Phone
- 770-717-0904
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000018 | 000 |
| P000018 | 040 |