FDA UDI
In Commercial Distribution
🇺🇸 United States
Lacrimal Probe
DI: 00841668108840
·
Model: K7-2623
·
KATENA PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lacrimal Probe
- Primary DI
- 00841668108840
- Version / Model
- K7-2623
- Catalog Number
- K7-2623
- Company Name
- KATENA PRODUCTS, INC.
- Labeler DUNS
- 085668598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-14
- Public Version
- 3
- Public Version Date
- 2022-12-15
- Public Version Status
- Update
- Public Device Record Key
- 8f9fc4c1-5832-4dbc-96dd-71a9891c79c2
Device Description
CRAWFORD RETRIEVING HOOK
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNL | Probe, lachrymal | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63399 | Lacrimal tube insertion hook/pusher | A hand-held manual instrument intended for introducing a lacrimal tube/stent into the canaliculi, nasolacrimal duct, and/or nasal cavity through the corner of the eye, during a lacrimal intubation procedure for treating pathologies of the tear drainage system. It may be in the form of a cylinder for pushing the lacrimal tube downwards into the nasal cavity [post-osteotomy during canalicular bypass surgery, dacryocystorhinostomy (DCR)], or a pigtail hook probe that is inserted into the canaliculi through one lacrimal duct punctum and rotated for retrieval via the other punctum, leaving the attached lacrimal tube to be inserted in the canaliculi. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841668108840 | GS1 |
Customer Contacts
- Phone
- +1(973)989-1600
- [email protected]