← Back to catalogue

OHBVE Biconcave Vitrectomy Lens w/Hexagonal Handle

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 7944

by Ocular Instruments Inc.

Identity

Trade Name
OHBVE Biconcave Vitrectomy Lens w/Hexagonal Handle EUDAMED
Biconcave Vitrectomy Lens w/Hexagonal Handle FDA UDI
Generic Name
Vitrectomy contact lens, reusable FDA UDI
Device Name
Contact Ophthalmic EUDAMED
Model / Reference
7944 EUDAMED
OHBVE FDA UDI

Identifiers

Primary DI / UDI-DI
00630238079440 EUDAMEDFDA UDI
Basic UDI-DI
06302381262637 EUDAMED
Direct Marketing DI
00630238079457 EUDAMED
510(k) Number
K864418 FDA UDI
FDA Product Code
HJK FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Vitrectomy contact lens, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
886.1385 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

OHBVE Biconcave Vitrectomy Lens w/Hexagonal Handle by Ocular Instruments, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ocular Instruments Inc.
EUDAMED SRN
US-MF-000007216
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 391919c6-30f1-4e46-afeb-7f49e1ee7689 61 fields · synced Jul 10, 2026
  • FDA UDI c56f2aa7-ebf4-445b-965d-4161c5216613 33 fields · synced May 30, 2026
  • FDA 510(k) K875331 1 fields · synced May 18, 2026