SC3001

GUDID 00845384017431

G1 Electric Console, Without Irrigation

Anspach Effort, The

Multi-purpose surgical power tool system, line-powered Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered Surgical power tool system control unit, line-powered

• Primary Device ID: 00845384017431
• NIH Device Record Key: c330c2a6-e02e-4a7e-80ca-500b610df4cc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SC3001
• Catalog Number: SC3001
• Company DUNS: 079116867
• Company Name: Anspach Effort, The
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845384017431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133604

FDA Product Code

• HBC: MOTOR, DRILL, ELECTRIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-09

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• 00845384018520 - KINCISE™: 2020-05-06 KINCISE AUTOMATED SURGICAL IMPACTOR
• 00845384018537 - KINCISE™: 2020-05-06 KINCISE RECHARGEABLE LI-ION BATTERY
• 00845384018544 - KINCISE™: 2020-05-06 KINCISE 4-PORT BATTERY CHARGER
• 00845384018551 - KINCISE™: 2020-05-06 KINCISE POSTERIOR BROACH ADAPTER
• 00845384018568 - KINCISE™: 2020-05-06 KINCISE ANTERIOR BROACH ADAPTER