FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196115945
·
Model: DYK1073585E
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196115945
- Version / Model
- DYK1073585E
- Catalog Number
- DYK1073585E
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9507ebc0-87fd-46ef-8ce7-04ba9d6e243b
Device Description
KIT,POST OP EYE,TRIDENT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJK | Eye tray | Ophthalmic | 886.4790 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30931 | Moisture chamber spectacles | A personal protective device used to shield the eyes of an individual by forming a semi-closed chamber around each eye to retain the natural eye moisture and help keep the eyes lubricated. It consists of a spectacle frame with a pair of spectacle lenses (typically made of plastic or glass) and enclosing shields attached to the sides of the frame to form the chambers. The spectacle lenses may be prescription or non-prescription. The enclosing shields are available in various designs and will fit tightly around the facial contours of the eye sockets. This device is used after an eye operation or for a person with sensitive eyes and/or skin around the eyes. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40080196115946 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10080196115945 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]