FDA UDI
In Commercial Distribution
🇺🇸 United States
Vu a-POD
DI: 10889981121259
·
Model: 21-40-0190
·
SEASPINE ORTHOPEDICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vu a-POD
- Primary DI
- 10889981121259
- Version / Model
- 21-40-0190
- Catalog Number
- 21-40-0190
- Company Name
- SEASPINE ORTHOPEDICS CORPORATION
- Labeler DUNS
- 079840876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5645bc73-cf2f-4ddd-9325-4676de9df6b5
Device Description
Spin Plate Snap Tool
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58098 | Internally-anchored endoscopic retractor sleeve | A non-sterile, interchangeable, tubular device (sleeve) designed to be attached (screwed or snapped) to a dedicated applier and perform through a compatible endoscopic instrument (e.g., an access port) to insert an internally-anchored endoscopic retractor for hands-free retraction of a selected internal organ during a laparoscopic or thoracoscopic procedure. It is available in various diameters and lengths to accommodate various size internal retractors; after completion of the procedure it is used for extraction of the retractor. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889981121259 | GS1 |
Customer Contacts
- Phone
- +1(760)727-8399
- [email protected]