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Disposable Backflush instrument, with brush needle 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
Disposable Backflush instrument, with brush needle and active aspiration. FDA UDI
Generic Name
Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
Device Name
Disposable Backflush instrument, with brush needle and active aspiration.(25 gauge / 0.5 mm) FDA UDI
Model / Reference
1281.BTD05 FDA UDI
Description
Disposable Backflush instrument, with brush needle and active aspiration.(25 gauge / 0.5 mm) FDA UDI

Identifiers

Catalog Number
1281.BTD05 FDA UDI
Primary DI / UDI-DI
08717872003818 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

Disposable Backflush instrument, with brush needle and active aspiration. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — FDA…

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 cbd9eb14-6cd1-44f6-b468-28b4e0d5a2a0 34 fields · synced May 29, 2026