FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Castroviejo Caliper (non glare), refurb.
DI: 10697660003525
·
Model: 25-140R
·
Oculo-Plastik Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Castroviejo Caliper (non glare), refurb.
- Primary DI
- 10697660003525
- Version / Model
- 25-140R
- Company Name
- Oculo-Plastik Inc
- Labeler DUNS
- 257382580
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-21
- Public Version
- 2
- Public Version Date
- 2022-03-25
- Public Version Status
- Update
- Public Device Record Key
- a06c0292-48bf-4a45-bc46-b683f81b5c49
- Distribution End Date
- 2022-03-24
Device Description
The Caliper is a measuring instrument intended to measure the skin or the eyelids' muscles that the surgeon wants to remove or shorten. The instrument touches directly onto the patient's eyelid and tissue that will be operated. It is partially non-glare: the ruler is not surface treated. It is usually used before the laser. Full scale is 20 mm and resolution is 0.5 mm.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35787 | Ophthalmic calliper | A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10697660003525 | GS1 |
Customer Contacts
- Phone
- 514-381-3292
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Full scale 20mm | ||
| Device Size Text, specify | Resolution 0.5mm |