ISOTECHNICS

GUDID M454U400D2PP2901

POSTERIOR CHAMBER INTRAOCULAR LENS

EYEKON MEDICAL, INC.

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: M454U400D2PP2901
• NIH Device Record Key: 5dd9c167-973a-4666-b40b-ed7f533f639e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOTECHNICS
• Version Model Number: U400D-2P-29.0
• 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	M454U400D2PP2901 [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 [ISOTECHNICS]

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• M454UN50AP2901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2551: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2501: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2451: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2401: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2351: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454UN50AP2251: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454UN50AP2101: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2051: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP2001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1551: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1501: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1451: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1401: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1351: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1301: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1251: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1201: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1151: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1101: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1051: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP1001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454UN50AP0551: POSTERIOR CHAMBER INTRAOCULAR LENS