Deluxe Laparoscopic Instruments

GUDID 00842102114670

Deluxe Peritoneal Scissor, Serrated Blades, 5mm x 36cm, Insert Only

FLEXBAR MACHINE CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 00842102114670
• NIH Device Record Key: 0b05cbf8-a280-4de6-9c14-c8db0d8f92be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deluxe Laparoscopic Instruments
• Version Model Number: 91661-D-I
• Company DUNS: 047644935
• Company Name: FLEXBAR MACHINE CORPORATION
• 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: false
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00842102114670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974382

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

[00842102114670]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-04
• Device Publish Date: 2021-09-24

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• 00842102115929 - Flexarm Surgical Holders and Positioners: 2024-05-13 Table Rail Clamp
• 00842102115851 - StrongArm Surgical Holders and Positioners: 2024-04-26 StrongArm Plus Front Mount w/ Short Distal Arm, attached Clasper (no Rail Clamp)
• 00842102115868 - StrongArm Surgical Holders and Positioners: 2024-04-26 StrongArm Plus Front Mount w/ Short Distal Arm, attached Clasper, Rail Clamp
• 00842102115875 - Mediflex Universal Round Bar Table Mounted Retractor Systems: 2024-04-26 Universal TMR Blade, Wylie Renal Vein, Aluminum, 1x10"
• 00842102115882 - Mediflex Universal Round Bar Table Mounted Retractor Systems: 2024-04-26 Universal TMR Blade, Wylie Renal Vein, 1x10"
• 00842102115899 - DynaTrac Retractor Frame: 2024-04-26 DynaTrac Frame, Horesehoe, 8.4" (21.3cm) x 7.8" (19.8cm)