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Unfolder Emerald

FDA UDI

Class I (US FDA UDI)

by Johnson & Johnson Surgical Vision, Inc.

Identity

Trade Name
UNFOLDER EMERALD FDA UDI
Generic Name
Manual intraocular lens injector, reusable FDA UDI
Device Name
MODEL EMERALDXL HANDPIECE, 690735 FDA UDI
Model / Reference
EMERALDXL FDA UDI
Description
MODEL EMERALDXL HANDPIECE, 690735 FDA UDI

Identifiers

Catalog Number
EMERALDXL FDA UDI
Primary DI / UDI-DI
15050474534503 FDA UDI
510(k) Number
K961242 FDA UDI
FDA Product Code
KYB FDA UDI
GMDN Term
Manual intraocular lens injector, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual intraocular lens injector, reusable

Unfolder Emerald by Johnson & Johnson Surgical Vision, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual intraocular lens injector, reusable.

Cleared under the same submission

K961242 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Johnson & Johnson Surgical Vision, Inc.

Sources (1)

  • FDA UDI 2bf65e8a-fbf4-4e9a-885e-8cc8d9878746 36 fields · synced Jun 9, 2026