FDA UDI
In Commercial Distribution
🇺🇸 United States
RITLENG HOOK
DI: 13760087126256
·
Model: S1.1480
·
FCI S A S FCI 20 22
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RITLENG HOOK
- Primary DI
- 13760087126256
- Version / Model
- S1.1480
- 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
- ff6801a2-96f8-495c-b692-5b54efeda181
Device Description
A slender hand-held manual instrument with a hook at its distal end designed to be inserted through the nose to extract a tube, cannula, or probe previously inserted into the lacrimal drainage system (the lacrimal duct), by pulling it out through the nose. This is a reusable device.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNQ | Hook, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63391 | Transnasal lacrimal tube extractor | A slender hand-held manual instrument with a hook at its distal end designed to be inserted through the nose to extract a tube, cannula, or probe previously inserted into the lacrimal drainage system (the lacrimal duct), by pulling it out through the nose. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 13760087126256 | GS1 |