Deluxe Laparoscopic Instruments

GUDID 00842102114670

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

FLEXBAR MACHINE CORPORATION

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

Devices Manufactured by FLEXBAR MACHINE CORPORATION

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• 00842102116186 - Flexarm Surgical Holders and Positioners: 2025-02-24 Mount Post with Rail Clamp for Bronchoscope Flexible Holding Arm
• 00842102116124 - Bookler Table Mounted Retractor Systems: 2024-12-27 Bookler Blade, Slotted Malleable, 3 x 6 1/2" (7.6 x 16.5cm)
• 00842102116131 - Bookler Table Mounted Retractor Systems: 2024-12-27 Bookler Blade, Slotted Malleable, 2 x 6 1/2" (5.1 x 16.5cm)
• 00842102116148 - Bookler Table Mounted Retractor Systems: 2024-12-27 Blade, Malleable, 3 x 6" - no protective edge
• 00842102116155 - Bookler Table Mounted Retractor Systems: 2024-12-27 Blade, Malleable, 2 x 6" - no protective edge
• 00842102116162 - Bookler Table Mounted Retractor Systems: 2024-12-27 Blade, Malleable 1 1/2” x 6 1/2” - no protective edge
• 10842102116107 - TAS Medical, Inc. ZipClip: 2024-12-19 ZipClip Hook Scissor Tip, Disposable, Sterile