FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tricera™ Handpiece, Autoclavable
DI: 00859273007113
·
Model: R-10011
·
RELIGN CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tricera™ Handpiece, Autoclavable
- Primary DI
- 00859273007113
- Version / Model
- R-10011
- Catalog Number
- R-10011
- Company Name
- RELIGN CORPORATION
- Labeler DUNS
- 080031617
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 5
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 20f84a2f-fff5-4e12-97eb-67ffef7dcb0e
- Distribution End Date
- 2020-06-29
Device Description
Shaver Handpiece, Autoclavable
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", "Hydrogen Peroxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53617 | Arthroscopic shaver system handpiece, electrically-powered | A handle with attached cutting blade that is a component of an electrically-powered arthroscopic shaver system designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859273007113 | GS1 |
Customer Contacts
- Phone
- (866) 608-0131
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162770 | 000 |