SURFIX®

GUDID M248219027ND1

The SURFIX® ALPHA drilling guide is used to guide the drills while preparing the holes for the SURFIX® ALPHA Locking System fixation screws.

NEWDEAL

Surgical drill guide, reusable

• Primary Device ID: M248219027ND1
• NIH Device Record Key: 3973b1fe-9085-4c37-8010-5c5b89008947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURFIX®
• Version Model Number: 219027ND
• 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	10381780043041 [Primary]
HIBCC	M248219027ND1 [Secondary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[M248219027ND1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2017-05-26

On-Brand Devices [SURFIX®]

• M248MA007ND1: The drilling guide is placed in the plate on the bone and is used to guide the drilling of the b
• M248MA006ND1: The drilling guide is placed in the plate on the bone and is used to guide the drilling of the b
• M248219665ND1: The drilling guide is used to guide the drills while preparing the holes for the 6.5 mm fixation
• M248219645ND1: The drilling guide is used to guide the drills while preparing the holes for the 4.5 mm fixation
• M248219635ND1: The drilling guide is used to guide the drills while preparing the holes for the 3.5 mm fixation
• M248219035ND1: The SURFIX® ALPHA drilling guide for variable angle screws is used to guide the drills while pr
• M248219027ND1: The SURFIX® ALPHA drilling guide is used to guide the drills while preparing the holes for the
• M248SET101ND1: This lid is used to ensure closing of both trays numbers SET000ND and SET100ND.
• M248SET100ND1: This tray is used for transport and sterilization of the instruments that are specific to the os
• M248SET000ND1: This tray is used for transport and sterilization of the instruments that are not specific to th
• M248286340SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248286340ND1: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286338SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248286338ND1: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248286336SND1: Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys
• M248286336ND1: Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This
• M248529061ND1: This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the