TEW™ 438A1157B

GUDID M268438A1157B1

The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the operative site for the purposes of retracting delicate brain tissue during neurosurgical procedures. The BUDDE® Systems consist of an adjustable halo ring that rigidly attaches to a MAYFIELD® Skull Clamp or surgical table, flexible retractor arms, and various retractor blades and patty trays

INTEGRA LIFESCIENCES CORPORATION

Neurosurgical retraction system, brain

• Primary Device ID: M268438A1157B1
• NIH Device Record Key: c7164d29-19aa-490a-b368-4003a12f09a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEW™
• Version Model Number: 438A1157B
• Catalog Number: 438A1157B
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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
• 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780253280 [Primary]
HIBCC	M268438A1157B1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830332

FDA Product Code

• GZT: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Sterilization

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

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

[M268438A1157B1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-09-30
• Device Publish Date: 2016-07-26

On-Brand Devices [TEW™]

• M268438A1157D1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1157B1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1155D1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1155B1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1152D1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1152B1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1151D1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1151B1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1083D1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1083B1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1082D1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1082B1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1157C1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1157A1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1155C1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1155A1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1152C1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1152A1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1151C1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1151A1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1083C1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1083A1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1082C1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op
• M268438A1082A1: The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op