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BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name
BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria FDA UDI
Generic Name
Trial lens frame FDA UDI
Device Name
BK X/O (according to Kochniss), without convex cylinders, coated, inclusive trial lens case FDA UDI
Model / Reference
33101 FDA UDI
Description
BK X/O (according to Kochniss), without convex cylinders, coated, inclusive trial lens case FDA UDI

Identifiers

Primary DI / UDI-DI
04049584001030 FDA UDI
FDA Product Code
HPC FDA UDI
GMDN Term
Trial lens frame FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1405 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 79c319d6-c223-4646-b119-de1c2cac32bc 35 fields · synced Jun 8, 2026