B-BOP®

GUDID M248189202ND1

The holder is used to hold the plate and ease the handling during surgery.

NEWDEAL

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: M248189202ND1
• NIH Device Record Key: 84ed7c43-be30-42bb-b75f-84ef70662837
• Commercial Distribution Discontinuation: 2018-10-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: B-BOP®
• Version Model Number: 189202ND
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780052869 [Primary]
HIBCC	M248189202ND1 [Secondary]

FDA Product Code

• KIL: POSITIONER, SOCKET

Sterilization

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

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

Moist Heat or Steam Sterilization

[M248189202ND1]

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: 2017-05-26

On-Brand Devices [B-BOP®]

• M248189202ND1: The holder is used to hold the plate and ease the handling during surgery.
• M248189203ND1: The drilling guide is used to guide the drills while preparing the holes for fixation screws.
• M248189940ND1: The lid is part of the system used for transport and sterilization of instruments.
• M248189910ND1: The basis is part of the container which product number is 189900ND and that is used for transpo
• M248189900ND1: The sterilization container is used for transport and sterilization of instruments.