Identity
- Trade Name
- SUMMIT MEDICAL FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- COMFORT TIP, STERILE, MEDIUM EUDAMEDFDA UDI
- Model / Reference
- 2008 EUDAMEDFDA UDI
- Description
- COMFORT TIP, STERILE, MEDIUM FDA UDI
Identifiers
- Catalog Number
- 2008 FDA UDI
- Primary DI / UDI-DI
- 00810061911210 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810061911210 EUDAMED
- 510(k) Number
- K140352 FDA UDI
- FDA Product Code
- LZU FDA UDI
- EMDN Code
- Q020703 LACRIMAL DUCT PLUGS EUDAMED
- GMDN Term
- Lacrimal punctum plug FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.91 Millimeter FDA UDI
Category: Lacrimal punctum plug
Summit Medical by Krishna Imports Inc — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal punctum plug.
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- Diamatrix — Diamatrix · U
- Lacrimal Plug — RIVERPOINT MEDICAL LLC · U
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- SOFT PLUG® Silicone Punctum Plug — OASIS Medical, Inc. · U
- Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
- TearSaver® - 0.7 mm — FCI S A S FCI 20 22 · U
Cleared under the same submission
K140352 also covers:
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- SUMMIT MEDICAL — KRISHNA IMPORTS INC
- Stephens Instruments — KRISHNA IMPORTS INC
- Stephens Instruments — KRISHNA IMPORTS INC
- Stephens Instruments — KRISHNA IMPORTS INC
- Stephens Instruments — KRISHNA IMPORTS INC
- Stephens Instruments — KRISHNA IMPORTS INC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI 18f3b9d3-e2ca-471d-94d1-b7b5c09c564e 38 fields · synced Jun 19, 2026
- EUDAMED 820a519b-015c-4b72-b036-1597de2bd8a6 61 fields · synced Jun 14, 2026