SOLDERABLE STOP

GUDID 00192029017005

SOLDERABLE STOPS

TP ORTHODONTICS INC

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• Primary Device ID: 00192029017005
• NIH Device Record Key: 60a48890-3288-4911-a157-ee907e3f5fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLDERABLE STOP
• Version Model Number: 226-008
• Company DUNS: 005432299
• Company Name: TP ORTHODONTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]
GS1	00192029017005 [Primary]

FDA Product Code

• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC
• ECN: CLAMP, WIRE, ORTHODONTIC

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: 2021-02-23
• Device Publish Date: 2021-02-15

Devices Manufactured by TP ORTHODONTICS INC

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• 00192029008218 - CRIMPABLE HOOK: 2021-02-23 RIBBED CRIMPABLE HOOKS
• 00192029008225 - CRIMPABLE HOOK: 2021-02-23 COATED CRIMPABLE HOOKS
• 00192029008232 - CRIMPABLE HOOK: 2021-02-23 RIBBED CRIMPABLE HOOKS Oriented
• 00192029008249 - CRIMPABLE HOOK: 2021-02-23 CRIMPABLE HOOKS Oriented
• 00192029010501 - RX1 Metal Bracket Patient Kit: 2021-02-23 UP/LO 5-5 W JIGS 0.56 mm (0.022")
• 00192029010655 - RX1 Metal Bracket: 2021-02-23 UL LAT W JIGS 3.5 mm Torque +8, Tip +9 0.56 mm (0.022")
• 00192029010662 - RX1 Metal Bracket: 2021-02-23 UR LAT W JIGS 3.5 mm Torque +8, Tip +9 0.56 mm (0.022")