FDA device listing

Braunstein IVT marker,Braunstein, IVT Marker,Braunstein, IVT Marker, 4.0 - 3.5 mm, 7 cm,Braunstein Marker, 3.0/ 3.5…

FDA device listing 1090110828 · B&H Surgical Instrument

Key facts

Proprietary names Braunstein IVT marker,Braunstein, IVT Marker,Braunstein, IVT Marker, 4.0 - 3.5 mm, 7 cm,Braunstein Marker, 3.0/ 3.5 mm,Braunstein, Marker, 3.0 - 3.5 mm, 7 cm,Henderson Alignment marker, to mark the patient at the slit lamp, 11 mm,Henderson Alignment marker, to mark the patient at the slit lamp, 11 mm, 12.5 cm,Henderson Corneal Marker, to mark the axis, 11 mm, 13 cm,Hoffer Corneal Marker with Cross…
Owner/operator B&H Surgical Instrument
Owner/operator number 10056927
Product codes HMQ
Device names HMQ - Marker, Sclera
Device class Class I
Classification regulations (21 CFR) 886.4570
Review panels Ophthalmic
Registered establishments B&H SURGICAL INSTRUMENT
Establishment registrations 3013503739
FEI numbers 3013503739
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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