Brasseler USA

GUDID 00887919950073

GEM10 X-RAY SENSOR STARTER KIT

Peter Brasseler Holdings, LLC

Dental digital imaging sensor, intraoral

• Primary Device ID: 00887919950073
• NIH Device Record Key: 0aa005d2-c2a7-4bda-b439-31c789e3d3ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brasseler USA
• Version Model Number: 5028383U0
• Company DUNS: 082080136
• Company Name: Peter Brasseler Holdings, LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887919950073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221955

FDA Product Code

• MUH: System, x-ray, extraoral source, digital

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Brasseler USA]

• 00887919691082: K0281 ESX STARTER KIT 1P ESX KIT
• 00887919691051: V3-U
• 00887919691044: V3-LED-U
• 00887919691037: E350053 FORZA V3 NON OPTIC HP
• 00887919691020: E351053 FORZA V3 LED HP ONLY 1P
• 00887919687955: SG3BT30S BEAVERTAIL 1P US INSERT
• 00887919687948: SG3BT25S BEAVERTAIL 1P US INSERT
• 00887919687931: SG10U30DF UNIVERSAL #10 1P US INSERT
• 00887919687924: SG10U25DF UNIVERSAL #10 1P US INSERT
• 00887919687917: SG1000TB30S TRIPLE BEND 1P US INSERT
• 00887919687900: SG1000TB25S TRIPLE BEND 1P US INSERT
• 00887919687894: HG3BT30S BEAVERTAIL 1P US INSERT
• 00887919687887: HG3BT25S BEAVERTAIL 1P US INSERT
• 00887919687870: HG10U25S UNIVERSAL #10 1P US INSERT
• 00887919687863: HG10U30S UNIVERSAL #10 1P US INSERT
• 00887919687856: HG10U25DF UNIVERSAL #10 1P US INSERT
• 00887919687849: HG10U30DF UNIVERSAL #10 1P US INSERT
• 00887919687832: HG100S25S SLIM #100 1P US INSERT
• 00887919687825: HG100S30S SLIM #100 1P US INSERT
• 00887919687818: HG100S25DF SLIM #100 1P US INSERT
• 00887919687801: HG100S30DF SLIM #100 1P US INSERT
• 00887919687795: HG1000TB25S TRIPLE BEND#1000 1P US INSERT
• 00887919687788: HG1000TB30S TRIPLE BEND#1000 1P US INSERT
• 00887919687771: SG10U25S UNIVERSAL #10 1P US INSERT
• 00887919687764: SG10U30S UNIVERSAL #10 1P US INSERT
• 00887919687757: SG100S25S SLIM #100 1P US INSERT
• 00887919687740: SG100S30S SLIM #100 1P US INSERT
• 00887919687733: SG100S25DF SLIM #100 1P US INSERT
• 00887919687726: SG100S30DF SLIM #100 1P US INSERT
• 00887919679554: Y1002814 FORZA V3 NON OPTIC SET
• 00887919679530: Y1002813 FORZA V3 LED SET 1P
• 00887919643388: K0220 BIORACE STARTER KIT 1P BIORACE STARTER KIT
• 00887919641056: K0208 BC OBTURATION .06 KIT EndoSequence
• 00887919641032: K0207 BC OBTURATION .04 KIT EndoSequence
• 00887919639442: SEQ ENDO COMPLETE SYSTEM IV 1P INTRO CASE W/ HANDPIECE
• 00887919639435: SEQ ENDO STARTER KIT IV 1P W/O HANDPIECE D5069
• 00887919632993: K0189 LARGE GROUP SEQ STARTER KIT 1P
• 00887919595755: SEQ109 MIXING POST TIP 1P 48PCS SEQ CORE MATERIAL
• 00887919581390: SEQ104 INTRO SYRINGE KIT 1P SEQ CORE MATERIAL
• 00887919581383: SEQ103 WHITE SYRINGE KIT 1P SEQ CORE MATERIAL
• 00887919581376: SEQ102 A2 SYRINGE KIT 1P SEQ CORE MATERIAL
• 00887919581369: SEQ106 MIXING TIP CARTR 1P 48PCS SEQ CORE MATERIAL
• 00887919581352: SEQ105 INTRA TIP CARTR 1P 48PCS SEQ CORE MATERIAL
• 00887919581345: SEQ101 WHT CARTRIDGE KIT 1P 25ML SEQ CORE MATERIAL
• 00887919581338: SEQ100 A2 CARTRIDGE KIT 1P 25ML SEQ CORE MATERIAL
• 00887919577669: SEQ108 GUN CARTRIDGE 1P SEQ CORE MATERIAL
• 00887919577652: SEQ107 INTRA & MIXING TIPS 1P COMBO TIP 48PC SEQ CORE MATERIA
• 00887919689836: BC RRM FAST SET PUTTY 1P .3G EndoSequence
• 00887919631996: BC RRM PUTTY 3G 1P EndoSequence
• 00887919631972: BC RRM 1.5G 2P EndoSequence