MIRA IMEX Scleral Buckling Component

GUDID 20850510007198

MIRA, INC.

Scleral buckling device, non-bioabsorbable

• Primary Device ID: 20850510007198
• NIH Device Record Key: 0fc8b952-7136-4ffc-9433-d1173de69dd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRA IMEX Scleral Buckling Component
• Version Model Number: 278
• Company DUNS: 001414358
• Company Name: MIRA, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *room temperature
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850510007191 [Primary]
GS1	20850510007198 [Package]; Contains: 10850510007191; Package: box of five [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950806

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: 2016-09-24

On-Brand Devices [MIRA IMEX Scleral Buckling Component]

• 20850510007440: 519G
• 20850510007433: 517
• 20850510007426: 516G
• 20850510007419: 511
• 20850510007402: 510
• 20850510007396: 509G
• 20850510007389: 509
• 20850510007372: 508G
• 20850510007365: 508
• 20850510007358: 507T
• 20850510007341: 507G
• 20850510007334: 507
• 10850510007320: 506G
• 20850510007310: 506
• 20850510007303: 505T
• 20850510007297: 505G
• 20850510007280: 505
• 20850510007273: 504
• 20850510007266: 503
• 20850510007259: 5025
• 20850510007242: 502
• 20850510007235: 501
• 20850510007228: 287
• 20850510007211: 286
• 20850510007204: 279
• 20850510007198: 278
• 20850510007181: 277
• 20850510007174: 276
• 20850510007167: 270
• 20850510007150: 250
• 20850510007143: 240
• 20850510007136: 225
• 10850510007122: 220
• 20850510007112: 219
• 20850510007105: 106
• 20850510007099: 75R
• 10850510007085: 72
• 10850510007078: 70
• 20850510007068: 50
• 20850510007051: 42
• 20850510007044: 41
• 20850510007037: 40
• 10850510007023: 32
• 20850510007013: 20
• 10850510007009: 5