DMEK/DSAEK Infusion Sleeve

GUDID 10632307002202

DMEK/DSAEK Infusion Sleeve

PEREGRINE SURGICAL, LTD.

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 10632307002202
• NIH Device Record Key: bd9d3616-3cd7-4840-8173-5676df0551c3
• Commercial Distribution Discontinuation: 2018-05-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DMEK/DSAEK Infusion Sleeve
• Version Model Number: PD500.27
• Company DUNS: 622467348
• Company Name: PEREGRINE SURGICAL, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 215-348-0456
• Email: jayne@peregrine-surgical.com
• Phone: 215-348-0456
• Email: jayne@peregrine-surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00632307002205 [Primary]
GS1	10632307002202 [Package]; Contains: 00632307002205; Package: [5 Units]; Discontinued: 2018-05-15; Not in Commercial Distribution

FDA Product Code

• KYG: Device, Irrigation, Ocular Surgery

Sterilization

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

[10632307002202]

Ethylene Oxide

[10632307002202]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-02-01

On-Brand Devices [DMEK/DSAEK Infusion Sleeve]

• 10632307002240: DMEK/DSAEK Infusion Sleeve
• 10632307002202: DMEK/DSAEK Infusion Sleeve