FDA UDI
In Commercial Distribution
🇺🇸 United States
Tricera™ Controller
DI: 00859273007014
·
Model: R-10001
·
RELIGN CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tricera™ Controller
- Primary DI
- 00859273007014
- Version / Model
- R-10001
- Catalog Number
- R-10001
- Company Name
- RELIGN CORPORATION
- Labeler DUNS
- 080031617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 4
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- f11e31dc-c335-45f5-ad44-ff419e0941bf
Device Description
System Controller with Footswitch
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52529 | Arthroscopic shaver/electrosurgical system generator | A mains electricity (AC-powered) device designed to provide energy for a system designed to perform arthroscopic shaving (i.e., abrasion, resection, debridement of bone and soft tissue with a blade) and electrosurgical diathermy (i.e., the ablation and coagulation of soft tissue, as well as haemostasis of blood vessels, with an electrosurgical probe) during arthroscopic procedures on a joint. The unit typically consists of an operational display, operator controls, and software to help provide optimal parameters for the connected shaver handpiece(s) and electrosurgical probe(s). It may include an irrigation system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859273007014 | GS1 |
Customer Contacts
- Phone
- (866) 608-0131
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162770 | 000 |