Identity
- Trade Name
- STENTube Lacrimal Intubation Set FDA UDI
- Generic Name
- Lacrimal intubation set FDA UDI
- Model / Reference
- LIS052 FDA UDI
Identifiers
- Catalog Number
- LIS052 FDA UDI
- Primary DI / UDI-DI
- 10634624815527 FDA UDI
- 510(k) Number
- K113118 FDA UDI
- FDA Product Code
- OKS FDA UDI
- GMDN Term
- Lacrimal intubation set FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lacrimal intubation set
STENTube Lacrimal Intubation Set by Quest Medical Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113118 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Quest Medical Inc
Sources (1)
- FDA UDI 4e83ffab-ce1a-4f46-898d-9f35cb2c6d2d 34 fields · synced Jun 6, 2026