FDA UDI
In Commercial Distribution
🇺🇸 United States
EXTERNAL OCULID MEDIUM BROWN® - 0,8 g
DI: 13700773727671
·
Model: S3.60083
·
FCI S A S FCI 20 22
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EXTERNAL OCULID MEDIUM BROWN® - 0,8 g
- Primary DI
- 13700773727671
- Version / Model
- S3.60083
- Company Name
- FCI S A S FCI 20 22
- Labeler DUNS
- 763408366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-08
- Public Version
- 1
- Public Version Date
- 2022-03-16
- Public Version Status
- New
- Public Device Record Key
- 28d91e0c-0c47-4054-8ce0-affbfac859cf
Device Description
EXTERNAL OCULID MEDIUM BROWN® - 0,8 g
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MML | Weights, Eyelid, External | Ophthalmic | 886.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18142 | Eyelid weight, external | An ophthalmic device that is applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device can be used for: 1) the treatment of temporary facial paralysis caused by Bell's palsy, trauma, or a stroke; or 2) to determine the appropriate size of implantable eyelid weights prior to surgery. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material (e.g., tantalum). It is worn just above the eyelashes, adhered to the skin with double-sided adhesive tape, and is coloured in a variety of skin shades (pink, tan, brown, dark brown). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 13700773727671 | GS1 |