LARGE UNI-CLIP®

GUDID M248119322ND1

The straight drilling guide, positionned with the osteotomy centered between the two sleeves, is used to guide the drills while drilling the holes for the straight staples.

NEWDEAL

Surgical drill guide, reusable

• Primary Device ID: M248119322ND1
• NIH Device Record Key: f6ace36e-4c49-47e8-abaf-ca63a4fd30a0
• Commercial Distribution Discontinuation: 2018-10-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LARGE UNI-CLIP®
• Version Model Number: 119322ND
• Company DUNS: 536935331
• Company Name: NEWDEAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780051930 [Primary]
HIBCC	M248119322ND1 [Secondary]

FDA Product Code

• HXJ: STAPLE DRIVER

Sterilization

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

[M248119322ND1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2017-05-31

On-Brand Devices [LARGE UNI-CLIP®]

• M248119324ND1: The offset drilling guide, positionned with the osteotomy centered between the two sleeves, is u
• M248119322ND1: The straight drilling guide, positionned with the osteotomy centered between the two sleeves, is
• M248119994ND1: The tray is part of the container with reference 119990ND, used in the transport and the sterili
• M248119993ND1: The propylux cylinder maintains the K-wires in the container with reference 119990ND used in the
• M248119992ND1: The silicone base is part of the container with reference 119990ND used in the transport and the
• M248119991ND1: The radel lid is part of the container with reference 119990ND used in the transport and the ste
• M248119990ND1: The sterilisation container is used in the transport and the sterilization of the LARGE UNI-CLIP