BENCO DENTAL 5952-454

GUDID 00850144008864

BENCO Sterilization Tubing with Indicator 4" ROLL X 100 FEET (4"X100')

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use

• Primary Device ID: 00850144008864
• NIH Device Record Key: e732e613-343a-4374-90c9-00e7e7f8c1a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENCO DENTAL
• Version Model Number: FL 1030
• Catalog Number: 5952-454
• Company DUNS: 565751992
• Company Name: PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com
• Phone: +903242387042
• Email: derya.dikici@pmsmedikal.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850144008864 [Package]; Contains: 00850144008949; Package: Inner Box [1 Units]; In Commercial Distribution
GS1	00850144008888 [Package]; Package: CASE [6 Units]; In Commercial Distribution
GS1	00850144008949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162362

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [BENCO DENTAL]

• 00850144008840: BENCO Sterilization Tubing with Indicator 2" ROLL X 100 FEET (2"X100')
• 00850144008871: BENCO Sterilization Tubing with Indicator 6" ROLL X 100 FEET (6"X100')
• 00850144008864: BENCO Sterilization Tubing with Indicator 4" ROLL X 100 FEET (4"X100')
• 00850144008857: BENCO Sterilization Tubing with Indicator 3" ROLL X 100 FEET (3"X100')