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Replacement backflush reservoir with active aspiration.

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name
Replacement backflush reservoir with active aspiration. FDA UDI
Generic Name
Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
Model / Reference
1281.XD FDA UDI

Identifiers

Catalog Number
1281.XD FDA UDI
Primary DI / UDI-DI
08717872004013 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

Replacement backflush reservoir with active aspiration. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — FDA UDI — listed in 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 30d46d6c-67f2-41f5-b8d2-3f62dd431930 33 fields · synced Jun 8, 2026