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Eyetec

FDA UDI

Class II (US FDA UDI)

by Network Medical Products, Ltd.

Identity

Trade Name
Eyetec FDA UDI
Generic Name
Ophthalmic sponge FDA UDI
Device Name
1-821 Lasik Shield 8mm Diameter 6mm Edge 1 Piece per Unit Non-sterile FDA UDI
Model / Reference
1-821 FDA UDI
Description
1-821 Lasik Shield 8mm Diameter 6mm Edge 1 Piece per Unit Non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI
05056100707078 FDA UDI
510(k) Number
K130117 FDA UDI
FDA Product Code
HOZ FDA UDI
GMDN Term
Ophthalmic sponge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4790 FDA UDI
Commercial Distribution
Not 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

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

Eyetec by Network Medical Products, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130117 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Network Medical Products, Ltd.

Sources (1)

  • FDA UDI 6b836abf-073e-41f0-a9ed-ca1642c3d74a 35 fields · synced May 31, 2026