FDA UDI
Not in Commercial Distribution
🇺🇸 United States
mi-eye 2 95mm
DI: 00861578000331
·
Model: T200-095
·
TRICE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- mi-eye 2 95mm
- Primary DI
- 00861578000331
- Version / Model
- T200-095
- Company Name
- TRICE MEDICAL, INC.
- Labeler DUNS
- 009452895
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-09
- Public Version
- 5
- Public Version Date
- 2025-03-03
- Public Version Status
- Update
- Public Device Record Key
- b9a1bb73-028c-4859-8ffc-a0ccba7404c1
- Distribution End Date
- 2025-02-28
Device Description
mi-eye 2 probe 95mm length for use with Trice Tablet 2
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62570 | Rigid optical arthroscope, single-use | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint [e.g., knee, shoulder, elbow, temporomandibular joint (TMJ)]. It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The eyepiece is normally interfaced with a video camera. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861578000331 | GS1 |
Customer Contacts
- Phone
- 610-989-8080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162475 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 95 | Millimeter |