DGR

GUDID M454CS55B0UVP1051

POSTERIOR CHAMBER INTRAOCULAR LENS

EYEKON MEDICAL, INC.

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: M454CS55B0UVP1051
• NIH Device Record Key: 1a4bfa4a-5458-4af6-af01-d34a1d07b1dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DGR
• Version Model Number: CS55B-0UV-10.5
• Company DUNS: 803926252
• Company Name: EYEKON MEDICAL, 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: true
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M454CS55B0UVP1051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880072

FDA Product Code

• HQL: Intraocular Lens

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-08
• Device Publish Date: 2015-09-18

On-Brand Devices [DGR]

• M454TC65BSUVP3001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2551: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2501: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2451: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2401: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2351: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2301: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2251: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2201: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2151: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2101: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2051: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP2001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1551: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1501: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1451: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1401: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1351: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1301: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1251: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1201: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1151: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1101: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1051: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP1001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454TC65BSUVP0551: POSTERIOR CHAMBER INTRAOCULAR LENS