SurgiLux™ SL-12

GUDID M710SL122

BIOTEX, INC.

Operating light

• Primary Device ID: M710SL122
• NIH Device Record Key: c1ec1083-5af4-4543-8987-535d8dac1283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiLux™
• Version Model Number: SL-12
• Catalog Number: SL-12
• Company DUNS: 969792050
• Company Name: BIOTEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M710SL120 [Primary]
HIBCC	M710SL122 [Package]; Contains: M710SL120; Package: Dispenser & 1-pack [12 Units]; In Commercial Distribution
HIBCC	M710SL124 [Package]; Contains: M710SL120; Package: 4-pack [48 Units]; In Commercial Distribution

FDA Product Code

• FTD: Lamp, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-09
• Device Publish Date: 2019-07-01

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