81 D-Lens

FDA UDI

Class II (US FDA UDI)

by Haag-Streit AG

Identity

Trade Name: 81 D-Lens FDA UDI
Generic Name: Ophthalmic diagnostic condensing lens FDA UDI
Model / Reference: 81 D-Lens FDA UDI

Identifiers

Catalog Number: 1400257 FDA UDI
Primary DI / UDI-DI: 07640132986518 FDA UDI
510(k) Number: K051103 FDA UDI
FDA Product Code: HJK FDA UDI
GMDN Term: Ophthalmic diagnostic condensing lens FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic diagnostic condensing lens

81 D-Lens by Haag-Streit AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K051103 also covers:

Contact glass 906 S — Haag-Streit AG

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 II	Pending data

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Manufacturer

Manufacturer: Haag-Streit AG

Sources (1)

FDA UDI 8adf81e2-f87c-4402-b539-76133ac625a6 35 fields · synced May 30, 2026