FDA UDI
In Commercial Distribution
🇺🇸 United States
LacriCATH
DI: 20634624438525
·
Model: DCR508-BIT
·
QUEST MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LacriCATH
- Primary DI
- 20634624438525
- Version / Model
- DCR508-BIT
- Company Name
- QUEST MEDICAL INC
- Labeler DUNS
- 041810693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-18
- Public Version
- 4
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 90e76641-16a5-43f2-be61-edabe7f6603c
Device Description
LacriCATH kit DCR508-BIT contains two lacrimal duct catheters (5 mm), one AQL 1015 inflation device, and two LIS052 STENTube intubation devices.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OKS | Lacrimal Stents And Intubation Sets | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47929 | Lacrimal intubation set | A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20634624438525 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113867 | 000 |