Identity
- Trade Name
- Summit Medical FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Model / Reference
- 1638 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640072380 FDA UDI
- 510(k) Number
- K030300 FDA UDI
- FDA Product Code
- LZU FDA UDI
- GMDN Term
- Lacrimal punctum plug 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
No
FDA UDI
Category: Lacrimal punctum plug
Summit Medical by Summit Medical, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal punctum plug.
- SuperFlex — Katena Products, Inc. · U
- Diamatrix — Diamatrix · U
- Lacrimal Plug — RIVERPOINT MEDICAL LLC · U
- Comfortear Lacrisolve 180 Absorbable Punctum Plug — RIVERPOINT MEDICAL LLC · U
- Diamatrix — Diamatrix · U
- SOFT PLUG® Silicone Punctum Plug — OASIS Medical, Inc. · U
- Stephens Instruments — KRISHNA IMPORTS INC · U
- Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
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 U | Pending data |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (1)
- FDA UDI 5879f99e-6bcb-4273-a5ed-c1fa52f620ff 34 fields · synced Jun 1, 2026