TEW? 438A1157C

GUDID 10381780253297

Budde® TEW™ 4mm x 6-1/2" Serrated Micro

INTEGRA LIFESCIENCES CORPORATION

Neurosurgical retraction system, brain

• Primary Device ID: 10381780253297
• NIH Device Record Key: 349e8aae-4a6e-470d-87d7-25ebd15664f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEW?
• Version Model Number: 438A1157C
• Catalog Number: 438A1157C
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780253297 [Previous]
GS1	10381780537854 [Primary]

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

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

[10381780253297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-08
• Device Publish Date: 2024-06-28

On-Brand Devices [TEW?]

• 10381780253303: Budde® TEW™ 4mm x 7-1/2" Serrated Micro
• 10381780253297: Budde® TEW™ 4mm x 6-1/2" Serrated Micro
• 10381780537847: Budde® TEW™ 4mm x 5-1/2" Serrated Micro
• 10381780537830: Budde® TEW™ 4mm x 4-1/2" Serrated Micro
• 10381780537823: Budde® TEW™ 2mm x 7-1/2" Serrated Micro
• 10381780253259: Budde® TEW™ 2mm x 6-1/2" Serrated Micro
• 10381780537809: Budde® TEW™ 2mm x 5-1/2" Serrated Micro
• 10381780537793: Budde® TEW™ 2mm x 4-1/2" Serrated Micro
• 10381780253181: Budde® TEW™ 4mm x 7-1/2" Hooked Micro
• 10381780537731: Budde® TEW™ 4mm x 6-1/2" Hooked Micro
• 10381780253167: Budde® TEW™ 4mm x 5-1/2" Hooked Micro
• 10381780253150: Budde® TEW™ 4mm x 4-1/2" Hooked Micro
• 10381780537700: Budde® TEW™ 2mm x 7-1/2" Hooked Micro
• 10381780253136: Budde® TEW™ 2mm x 6-1/2" Hooked Micro
• 10381780537687: Budde® TEW™ 2mm x 5-1/2" Hooked Micro
• 10381780253112: Budde® TEW™ 2mm x 4-1/2" Hooked Micro
• 10381780253105: Budde® TEW™ 4mm x 7-1/2" Micro
• 10381780537656: Budde® TEW™ 4mm x 6-1/2" Micro
• 10381780253082: Budde® TEW™ 4mm x 5-1/2" Micro
• 10381780537632: Budde® TEW™ 4mm x 4-1/2" Micro
• 10381780253068: Budde® TEW™ 2mm x 7-1/2" Micro
• 10381780537618: Integra® 2MM X 6.5 INCH RETRACTOR
• 10381780537601: Budde® TEW™ 2mm x 5-1/2" Micro
• 10381780537595: Budde® TEW™ 2MM X 4.5 INCH RETRACTOR