FDA UDI
In Commercial Distribution
🇺🇸 United States
Digital C.R.P
DI: 03615020000397
·
Model: X81705
·
ESSILOR INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Digital C.R.P
- Primary DI
- 03615020000397
- Version / Model
- X81705
- Company Name
- ESSILOR INTERNATIONAL
- Labeler DUNS
- 277373213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-09
- Public Version
- 1
- Public Version Date
- 2026-04-17
- Public Version Status
- New
- Public Device Record Key
- 0d32bf6d-29ab-4e7c-8c64-6dfc679f13ad
Device Description
The digital Corneal Reflection Pupillometer (CRP) enables the Eyecare professional to obtain a measurement of a patient's monocular and binocular pupillary distance and displays them digitally.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | Ophthalmic | 886.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67759 | Interpupillary distance meter, electronic | An electrically-powered, ophthalmic instrument, intended for use by a healthcare provider in a clinical setting to objectively measure the distance between the pupils of eyes, typically to ensure proper alignment when fitting spectacles. Also known as a pupilometer, it is a hand-held device with controls and display(s) intended to show the distance measurement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615020000397 | GS1 |
Customer Contacts
- Phone
- 817-262-3801
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity