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Disposable Instruments

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name
Disposable Instruments FDA UDI
Generic Name
Ophthalmic working-channel cannula, single-use FDA UDI
Device Name
Hydrodissection Cannula, 27g x 7/8” (0.4 x 22mm), 8mm Bend FDA UDI
Model / Reference
4036B, B-4036B FDA UDI
Description
Hydrodissection Cannula, 27g x 7/8” (0.4 x 22mm), 8mm Bend FDA UDI

Identifiers

Primary DI / UDI-DI
00845819001158 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Ophthalmic working-channel cannula, single-use 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
Sterilization Method
Radiation Sterilization FDA UDI

Category: Ophthalmic working-channel cannula, single-use

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Similar devices

Also classified as Ophthalmic working-channel cannula, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OASIS Medical, Inc.

Sources (1)

  • FDA UDI 38a1e0a5-44bc-4959-9fc0-1df9ae3b8370 34 fields · synced Jul 9, 2026