5431

GUDID 30818255011327

Concave Silicone Tire 7.0mm, 2.5mm groove

MICROVISION, INC.

Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable

• Primary Device ID: 30818255011327
• NIH Device Record Key: 527de07c-7f22-49ae-83aa-7a3d4831cd11
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Style 277
• Catalog Number: 5431
• Company DUNS: 013486803
• Company Name: MICROVISION, 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter
• Device Size Text, specify: 0
• Width: 7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818255011323 [Primary]
GS1	30818255011327 [Package]; Contains: 10818255011323; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023481

FDA Product Code

• HQX: Implant, Orbital, Extra-Ocular

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: 2021-12-22
• Device Publish Date: 2017-12-22

Devices Manufactured by MICROVISION, INC.

• 30818255011198 - NA: 2021-12-22 Round Silicone Sponge 3.0mm x 80mm
• 30818255011204 - NA: 2021-12-22 Round Silicone Sponge 4.0mm x 80mm
• 30818255011211 - NA: 2021-12-22 Round Silicone Sponge 5.0mm x 80mm
• 30818255011228 - NA: 2021-12-22 Oval Silicone Sponge 3.0mm x 5.0mm x 100mm
• 30818255011235 - NA: 2021-12-22 Oval Silicone Sponge 5.5mm x 7.5mm x 80mm
• 30818255011327 - NA: 2021-12-22Concave Silicone Tire 7.0mm, 2.5mm groove
• 30818255011327 - NA: 2021-12-22 Concave Silicone Tire 7.0mm, 2.5mm groove
• 30818255011334 - NA: 2021-12-22 Concave Silicone Tire 9.0mm, 2.5mm groove
• 30818255011372 - NA: 2021-12-22 Asymmetrical Silicone Tire 7.0mm, 2.5mm groove