Mediflex Deluxe Laparoscopic Instruments 91345-D26-I

GUDID 00842102101359

Deluxe Fenested Grasper, 15mm Double-Action, 5mm x 26cm, Insert Only

FLEXBAR MACHINE CORPORATION

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00842102101359
• NIH Device Record Key: 381f94f0-e355-40a1-b89b-39841dcd7bff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediflex Deluxe Laparoscopic Instruments
• Version Model Number: 91345-D26-I
• Catalog Number: 91345-D26-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	00842102101359 [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

[00842102101359]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-21
• Device Publish Date: 2016-09-17

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