Premier

GUDID D6919006503

ELECTROSURGERY UNIT 2001e-LOANER

PREMIER DENTAL PRODUCTS COMPANY

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator

• Primary Device ID: D6919006503
• NIH Device Record Key: 83cf34f5-b6ee-4ca5-a10e-4f781b6966b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier
• Version Model Number: 9006503
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: true
• 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
HIBCC	D6919006503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945492

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2023-04-04
• Device Publish Date: 2016-09-16

On-Brand Devices [Premier]

• 00856402006344: Decan Stopper Size 9 Closure Full
• 00856402006337: Decan Stopper Size 8 Closure Full
• 00856402006320: Decan Stopper Size 7 Closure Full
• 00856402006313: Decan Stopper Size 6 Closure Full
• 00856402006306: Decan Stopper Size 5 Closure Full
• 00856402006290: Decan Stopper Size 4 Closure Full
• 00856402006283: Decan Stopper Size 3 Closure Full
• 00856402006276: Decan Stopper Size 2 Closure Full
• 00856402006269: Decan Stopper Size 1 Closure Full
• 00856402006252: Decan Stopper Size 0 Closure Full
• 00856402006245: Decan Stopper Size 9 Closure 3/4
• 00856402006238: Decan Stopper Size 8 Closure 3/4
• 00856402006221: Decan Stopper Size 7 Closure 3/4
• 00856402006214: Decan Stopper Size 6 Closure 3/4
• 00856402006207: Decan Stopper Size 0 Closure 3/4
• 00856402006191: Decan Stopper Size 8 Closure 1/2
• 00856402006184: Decan Stopper Size 7 Closure 1/2
• 00856402006177: Decan Stopper Size 6 Closure 1/2
• 00856402006160: Decan Stopper Size 5 Closure 1/2
• 00856402006153: Decan Stopper Size 0 Closure 1/2
• 00856402006146: Decan Stopper Size 7 Closure 1/4
• 00856402006139: Decan Stopper Size 6 Closure 1/4
• 00856402006122: Decan Stopper Size 5 Closure 1/4
• 00856402006115: Decan Stopper Size 4 Closure 1/4
• 00856402006108: TT Air-Lon® Inhalation Set Sz 8
• 00856402006092: TT Air-Lon® Inhalation Set Sz 7
• 00856402006085: TT Air-Lon® Inhalation Set Sz 6
• 00856402006078: TT Air-Lon® Inhalation Set Sz 4
• 00856402006061: TT Air-Lon® Sz 8
• 00856402006054: TT Air-Lon® Sz 7
• 00856402006047: TT Air-Lon® Sz 6
• 00856402006030: TT Air-Lon® Sz 5
• 00856402006016: TT Air-Lon® Sz 4
• D6913001470: NEXTEMP CEMENT BULK KIT
• D6911040600: PESSARY FITTING SET (6)
• D6911040421: CUBE PESSARY W/O DRAINAGE HOLES #10
• D6911040420: CUBE PESSARY W/ DRAINAGE HOLES #10
• D6911040419: CUBE PESSARY W/O DRAINAGE HOLES #9
• D6911040418: CUBE PESSARY W/O DRAINAGE HOLES #8
• D6911040417: CUBE PESSARY W/O DRAINAGE HOLES #7
• D6911040416: CUBE PESSARY W/O DRAINAGE HOLES #6
• D6911040415: CUBE PESSARY W/O DRAINAGE HOLES #5
• D6911040414: CUBE PESSARY W/O DRAINAGE HOLES #4
• D6911040413: CUBE PESSARY W/O DRAINAGE HOLES #3
• D6911040412: CUBE PESSARY W/O DRAINAGE HOLES #2
• D6911040411: CUBE PESSARY W/O DRAINAGE HOLES #1
• D6911040410: CUBE PESSARY W/O DRAINAGE HOLES #0
• D6911040409: CUBE PESSARY W/ DRAINAGE HOLES #9
• D6911040408: CUBE PESSARY W/ DRAINAGE HOLES #8
• D6911040407: CUBE PESSARY W/ DRAINAGE HOLES #7