FDA UDI
In Commercial Distribution
🇺🇸 United States
StimTrial Patient Kit
DI: 00816986020570
·
Model: TS-6000
·
BIOVENTUS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StimTrial Patient Kit
- Primary DI
- 00816986020570
- Version / Model
- TS-6000
- Company Name
- BIOVENTUS LLC
- Labeler DUNS
- 078450878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 2
- Public Version Date
- 2026-03-27
- Public Version Status
- Update
- Public Device Record Key
- c4e6158e-f238-40da-afc2-da8b539677e5
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | 882.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65532 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporeal | An electrically-powered, external (noninvasive) component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to generate electrical impulses, for wireless (transcutaneous) transmission, to an implantable lead (situated adjacent to the epidural space and/or a peripheral nerve), to relieve acute and/or chronic intractable pain (analgesia); the implantable lead is not included. It is designed for continuous therapy (i.e., not a trial therapy device). The device is programmed, controlled, and charged by external devices which may be included with the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816986020570 | GS1 |
Customer Contacts
- Phone
- 888-453-2136
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243782 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 50 – 106 KiloPascal