Verisyse VRSM6US -9.0D

GUDID 08717819048001

Verisyse Myopia 6.0 mm -9.0D

Ophtec B.V.

Anterior-chamber intraocular lens, phakic

• Primary Device ID: 08717819048001
• NIH Device Record Key: bebb97ce-3268-495a-9494-766e6ccb8a75
• Commercial Distribution Discontinuation: 2018-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Verisyse
• Version Model Number: VRSM6US
• Catalog Number: VRSM6US -9.0D
• Company DUNS: 405048120
• Company Name: Ophtec B.V.
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717819048001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030028

FDA Product Code

• MTA: Lens, Intraocular, Phakic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-07-08
• Device Publish Date: 2015-08-24

On-Brand Devices [Verisyse]

• 08717819048131: Verisyse Myopia 6.0 mm -15.5D
• 08717819048124: Verisyse Myopia 6.0 mm -15.0D
• 08717819048117: Verisyse Myopia 6.0 mm -14.5D
• 08717819048100: Verisyse Myopia 6.0 mm -14.0D
• 08717819048094: Verisyse Myopia 6.0 mm -13.5D
• 08717819048087: Verisyse Myopia 6.0 mm -13.0D
• 08717819048070: Verisyse Myopia 6.0 mm -12.5D
• 08717819048063: Verisyse Myopia 6.0 mm -12.0D
• 08717819048056: Verisyse Myopia 6.0 mm -11.5D
• 08717819048049: Verisyse Myopia 6.0 mm -11.0D
• 08717819048032: Verisyse Myopia 6.0 mm -10.5D
• 08717819048025: Verisyse Myopia 6.0 mm -10.0D
• 08717819048018: Verisyse Myopia 6.0 mm -9.5D
• 08717819048001: Verisyse Myopia 6.0 mm -9.0D
• 08717819047998: Verisyse Myopia 6.0 mm -8.5D
• 08717819047981: Verisyse Myopia 6.0 mm -8.0D
• 08717819047974: Verisyse Myopia 6.0 mm -7.5D
• 08717819047967: Verisyse Myopia 6.0 mm -7.0D
• 08717819047950: Verisyse Myopia 6.0 mm -6.5D
• 08717819047943: Verisyse Myopia 6.0 mm -6.0D
• 08717819047936: Verisyse Myopia 6.0 mm -5.5D
• 08717819047929: Verisyse Myopia 6.0 mm -5.0D
• 08717819047615: Verisyse Myopia 5.0 mm -20.0D
• 08717819047608: Verisyse Myopia 5.0 mm -19.5D
• 08717819047592: Verisyse Myopia 5.0 mm -19.0D
• 08717819047585: Verisyse Myopia 5.0 mm -18.5D
• 08717819047578: Verisyse Myopia 5.0 mm -18.0D
• 08717819047561: Verisyse Myopia 5.0 mm -17.5D
• 08717819047554: Verisyse Myopia 5.0 mm -17.0D
• 08717819047547: Verisyse Myopia 5.0 mm -16.5D
• 08717819047530: Verisyse Myopia 5.0 mm -16.0D
• 08717819047523: Verisyse Myopia 5.0 mm -15.5D
• 08717819047516: Verisyse Myopia 5.0 mm -15.0D
• 08717819047509: Verisyse Myopia 5.0 mm -14.5D
• 08717819047493: Verisyse Myopia 5.0 mm -14.0D
• 08717819047486: Verisyse Myopia 5.0 mm -13.5D
• 08717819047479: Verisyse Myopia 5.0 mm -13.0D
• 08717819047462: Verisyse Myopia 5.0 mm -12.5D
• 08717819047455: Verisyse Myopia 5.0 mm -12.0D
• 08717819047448: Verisyse Myopia 5.0 mm -11.5D
• 08717819047431: Verisyse Myopia 5.0 mm -11.0D
• 08717819047424: Verisyse Myopia 5.0 mm -10.5D
• 08717819047417: Verisyse Myopia 5.0 mm -10.0D
• 08717819047400: Verisyse Myopia 5.0 mm -9.5D
• 08717819047394: Verisyse Myopia 5.0 mm -9.0D
• 08717819047387: Verisyse Myopia 5.0 mm -8.5D
• 08717819047370: Verisyse Myopia 5.0 mm -8.0D
• 08717819047363: Verisyse Myopia 5.0 mm -7.5D
• 08717819047356: Verisyse Myopia 5.0 mm -7.0D
• 08717819047349: Verisyse Myopia 5.0 mm -6.5D