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Backflush Instrument with 27ga / 0.4 mm soft-tip cannula and active aspiration

FDA UDI

Class I (US FDA UDI)

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Identity

Trade Name
Backflush Instrument with 27ga / 0.4 mm soft-tip cannula and active aspiration FDA UDI
Generic Name
Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
Model / Reference
2281.STD04 FDA UDI

Identifiers

Catalog Number
2281.STD04 FDA UDI
Primary DI / UDI-DI
08717872028484 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Vitrectomy fluid/gas handling handpiece/cannula FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vitrectomy fluid/gas handling handpiece/cannula

Backflush Instrument with 27ga / 0.4 mm soft-tip cannula and active aspiration by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I…

Similar devices

Also classified as Vitrectomy fluid/gas handling handpiece/cannula.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Sources (1)

  • FDA UDI d20b8053-9632-42d1-b745-c946d6c4b77b 33 fields · synced May 30, 2026