FDA UDI
In Commercial Distribution
🇺🇸 United States
Vein Pick
DI: 40836559009250
·
Model: VP52Y
·
Oscor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Vein Pick
- Primary DI
- 40836559009250
- Version / Model
- VP52Y
- Catalog Number
- VP52Y
- Company Name
- Oscor Inc.
- Labeler DUNS
- 101835833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-11-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5b2097e5-997b-4036-b1d7-e99c563862a1
Device Description
Vein Pick
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 |
|---|---|---|---|---|
| DTB | permanent pacemaker Electrode | Cardiovascular | 870.3680 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46226 | Vein pick | A small surgical instrument that is used to open an incision in a vein typically for the introduction of an implantable pacing lead (the electrode tip) into the vein. It is typically a long, hand-held instrument that tapers to a blunt point at its distal end and is typically made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 40836559009250 | GS1 | ||||
| Unit of Use | 00836559009245 | GS1 |
Customer Contacts
- Phone
- +1(727)937-2511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024053 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius