Identity
- Trade Name
- Visitec® FDA UDI
- Generic Name
- Lacrimal intubation set FDA UDI
- Device Name
- Lacrimal Intubation .60mm x 17.5cm (23G x 7in) 3 FDA UDI
- Model / Reference
- 585010 FDA UDI
- Description
- Lacrimal Intubation .60mm x 17.5cm (23G x 7in) 3 FDA UDI
Identifiers
- Catalog Number
- 585010 FDA UDI
- Primary DI / UDI-DI
- 30886158101216 FDA UDI
- 510(k) Number
- K831901 FDA UDI
- FDA Product Code
- HNL FDA UDI
- GMDN Term
- Lacrimal intubation set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Visitec® by Beaver-Visitec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal intubation set.
- Anodyne Surgical — Psi/Eye-Ko, Inc. · U
- V. Mueller — STERIS CORPORATION · Class I
- LACRIJET® 45 — FCI S A S FCI 20 22 · U
- LACRIJET® 50 — FCI S A S FCI 20 22 · U
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Crawford — JEDMED Instrument Company · U
- Lacrimal Intubation Set, Crawford Type — QUEST MEDICAL INC · U
- Crawford — JEDMED Instrument Company · U
Cleared under the same submission
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beaver-Visitec International, Inc.
Sources (1)
- FDA UDI 96331d81-967b-4d9f-9f80-2bba1aa492f8 36 fields · synced Jun 1, 2026