UNFOLDER EMERALD EMERALDXL

GUDID 15050474534503

MODEL EMERALDXL HANDPIECE, 690735

JOHNSON & JOHNSON SURGICAL VISION, INC.

Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable

• Primary Device ID: 15050474534503
• NIH Device Record Key: 2bf65e8a-fbf4-4e9a-885e-8cc8d9878746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNFOLDER EMERALD
• Version Model Number: EMERALDXL
• Catalog Number: EMERALDXL
• Company DUNS: 103021940
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	15050474534503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961242

FDA Product Code

• KYB: LENS, GUIDE, INTRAOCULAR

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

[15050474534503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-26
• Device Publish Date: 2019-02-13

On-Brand Devices [UNFOLDER EMERALD]

• 15050474530024: EMERALD CARTRIDGE-THERMOFORM TR, 30 BX
• 15050474534503: MODEL EMERALDXL HANDPIECE, 690735
• 15050474500126: PKG ASSY EMERALDT CE MARK HNDPC, 690694