Identity
- Trade Name
- SuperEagle FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- SuperEagle Punctum Plug, Medium, 0.6mm-0.8mm - 2 per box FDA UDI
- Model / Reference
- 31312 FDA UDI
- Description
- SuperEagle Punctum Plug, Medium, 0.6mm-0.8mm - 2 per box FDA UDI
Identifiers
- Catalog Number
- 31312 FDA UDI
- Primary DI / UDI-DI
- 00841668114414 FDA UDI
- 510(k) Number
- K991130 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
SuperEagle by Katena Products, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Lacrimal punctum plug.
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- Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
- TearSaver® - 0.7 mm — FCI S A S FCI 20 22 · U
Cleared under the same submission
K991130 also covers:
- EagleFlex — Katena Products, Inc.
- EagleFlex — Katena Products, Inc.
- EagleFlex — Katena Products, Inc.
- EagleFlex — Katena Products, Inc.
- EagleFlex — Katena Products, Inc.
- EagleFlex — Katena Products, Inc.
- EaglePlug — Katena Products, Inc.
- EaglePlug — Katena Products, Inc.
- EaglePlug — Katena Products, Inc.
- EaglePlug — Katena Products, Inc.
- EaglePlug — Katena Products, Inc.
- EaglePlug 1 — Katena Products, Inc.
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
- Katena Products, Inc.
Sources (1)
- FDA UDI 3820de91-3513-4152-af19-56283e9edabf 36 fields · synced Jun 12, 2026