FDA UDI
In Commercial Distribution
🇺🇸 United States
Algovita®
DI: 00821329580499
·
Model: 5208-20-USA
·
Greatbatch Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Algovita®
- Primary DI
- 00821329580499
- Version / Model
- 5208-20-USA
- Catalog Number
- 5208-20
- Company Name
- Greatbatch Ltd
- Labeler DUNS
- 968623467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 509c1c28-8fca-4178-b1f3-1311f44a77e6
Device Description
Lead Extension 8-Filar (1 X 8)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48054 | Neural-tissue electrical stimulation lead adaptor | A sterile implantable device intended to provide a functional and modified connection between existing neurostimulation leads and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821329580499 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius