UNFOLDER SILVER PSCST30

GUDID 15050474530031

SILVER CARTRIDGE THERMOFORMED TR, 30 BX

JOHNSON & JOHNSON SURGICAL VISION, INC.

Intraocular lens-insertion cartridge

• Primary Device ID: 15050474530031
• NIH Device Record Key: 269c3e83-f4dd-46e4-968b-47efe00a3b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNFOLDER SILVER
• Version Model Number: PSCST30
• Catalog Number: PSCST30
• Company DUNS: 103021940
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05050474530034 [Primary]
GS1	15050474530031 [Package]; Contains: 05050474530034; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961242

FDA Product Code

• KYB: LENS, GUIDE, INTRAOCULAR

Sterilization

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

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 SILVER]

• 15050474530031: SILVER CARTRIDGE THERMOFORMED TR, 30 BX
• 15050474523491: SILVER SERIES HANDPIECE (TWIST)