Hi-Pull

GUDID 00817573023998

HIGH PULL CAP COTTON 5/PK

LANCER ORTHODONTICS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00817573023998
• NIH Device Record Key: 63a5aab9-abd5-409b-809b-2d2f8d8dee00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hi-Pull
• Version Model Number: 830-304RM
• Company DUNS: 045545589
• Company Name: LANCER ORTHODONTICS, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817573023998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901958

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-15

On-Brand Devices [Hi-Pull]

• 00817573024100: HI-PULL STRAP BLUE LARGE 5/PK
• 00817573024094: HI-PULL STRAP BLUE MEDIUM 5/PK
• 00817573024087: HI-PULL STRAP BLUE SMALL 5/PK
• 00817573024070: HI-PULL STRIP BLUE EXTRA SMALL 5/PK
• 00817573024056: HI-PULL STRAP BLUE LARGE
• 00817573024049: HI-PULL STRAP BLUE MEDIUM
• 00817573024032: HI-PULL STRAP BLUE SMALL
• 00817573024025: HI-PULL STRAP EQUA-PULL ASRT 5/PK
• 00817573024001: HI-PULL STRAP W/SAFETYMODULE600g 1/PK
• 00817573023998: HIGH PULL CAP COTTON 5/PK
• 00817573023981: HIGH PULL CAP COTTON 5/PK