FDA UDI
In Commercial Distribution
🇺🇸 United States
FCI NUNCHAKU 105
DI: 03760087123746
·
Model: S1.1371
·
FCI S A S FCI 20 22
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FCI NUNCHAKU 105
- Primary DI
- 03760087123746
- Version / Model
- S1.1371
- 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
- 2021-05-30
- Public Version
- 1
- Public Version Date
- 2021-06-07
- Public Version Status
- New
- Public Device Record Key
- 30129547-8e80-4c32-a37c-9b7ad195c903
Device Description
FCI NUNCHAKU 105
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| OKS | Lacrimal Stents And Intubation Sets | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17003 | Lacrimal tube | An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 13760087123743 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 03760087123746 | GS1 |