Karl Schumacher

GUDID 00842517100008

Aspirating Syringe, 1.8ml, Cooke-Waite Style

KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

Dental anaesthesia syringe, reusable

• Primary Device ID: 00842517100008
• NIH Device Record Key: f9bb47a7-3c75-42da-b09e-76db533cf139
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karl Schumacher
• Version Model Number: SYR0001
• Company DUNS: 043957315
• Company Name: KARL SCHUMACHER DENTAL INSTRUMENT CO., 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: false
• 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: false

Device Dimensions

• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842517100008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120659

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

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

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

[00842517100008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-27

On-Brand Devices [Karl Schumacher]

• 00842517100008: Aspirating Syringe, 1.8ml, Cooke-Waite Style
• 00842517102743: Sm Tight Mesial Angle Prox, 2.5mm, Brown
• 00842517102736: Tight Mesial Spade Prox, 2.5mm, Brown
• 00842517102729: Aetranox Spade Proximator, Left, Yellow
• 00842517102712: Spade Proximator, Left, Yellow
• 00842517102705: Aetranox Spade Proximator, Right, Yellow
• 00842517102699: Spade Proximator, Right, Yellow
• 00842517102682: Aetranox Mesial Spade Proximator, Purple
• 00842517102675: Mesial Ang Spade Proximator, Purple
• 00842517102668: Aetranox Distal Spade Proximator, Purple
• 00842517102651: Distal Ang Spade Proximator, Purple
• 00842517102644: Lg Mesial Ang Proximator, 3.75mm, Yellow
• 00842517102637: Lg Distal Ang Proximator, 3.75mm, Yellow
• 00842517102620: Sm Mesial Ang Proximator, 2.5mm, Purple
• 00842517102613: Sm Distal Ang Proximator, 2.5mm, Purple
• 00842517102590: Aetranox Spade Proximator, Yellow
• 00842517102583: Spade Proximator, Yellow
• 00842517102576: Lg Cvd Proximator, 4.5mm Wide Tip, Blue
• 00842517102569: Sm Cvd Proximator, 2.5mm Wide Tip, Blue
• 00842517102552: Lg Str Proximator, 4.5mm Wide Tip, Green
• 00842517102545: Sm Str Proximator, 2.5mm Wide Tip, Green