FDA UDI
In Commercial Distribution
🇺🇸 United States
LYNKS Frontalis Sling
DI: 08800268430111
·
Model: LSFS-2
·
Lynk Solutec Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LYNKS Frontalis Sling
- Primary DI
- 08800268430111
- Version / Model
- LSFS-2
- Company Name
- Lynk Solutec Inc.
- Labeler DUNS
- 695160136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-03
- Public Version
- 1
- Public Version Date
- 2026-03-11
- Public Version Status
- New
- Public Device Record Key
- 2d35adde-5917-432f-af50-1614a939eccb
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62053 | Ptosis sling | A sterile implantable device intended for the surgical correction of ptosis (dropping of the eyelid). It typically consists of a thread made of synthetic polymer (e.g., silicone), which may have attached needles, implanted into the upper eyelid and possibly lower forehead (frontalis muscle) to mechanically elevate the lid. Also referred to as a frontalis sling, it is left in situ where the position/retraction may be adjusted during use. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800268430111 | GS1 |
Customer Contacts
- Phone
- 7042479103
- [email protected]