BUDDE®
GUDID M268S438A1200B1
SAMY™ Vascular Retractor Blade – Long 4.6"
INTEGRA LIFESCIENCES CORPORATION
Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain Neurosurgical retraction system, brain| Primary Device ID | M268S438A1200B1 |
| NIH Device Record Key | fe948fab-58c4-48c7-9502-d10c4c4f5c46 |
| Commercial Distribution Discontinuation | 2023-12-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BUDDE® |
| Version Model Number | S438A1200B |
| Company DUNS | 963856096 |
| Company Name | INTEGRA LIFESCIENCES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780355304 [Primary] |
| HIBCC | M268S438A1200B1 [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 |
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
[M268S438A1200B1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-04-05 |
| Device Publish Date | 2016-09-29 |
On-Brand Devices [BUDDE®]
| 10381780533689 | Aneurysm Retractor |
| 10381780533672 | Aneurysm Retractor |
| M268438A1194A1 | Aneurysm Retractor 7mm |
| M268438A1192A1 | Aneurysm Retractor 3mm |
| M268A10961 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268A1040A1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1154E1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1154C1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1077X1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1077D1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1077B1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268S438A11601 | BUDDE® Halo 6” Retractor Arm |
| M268438A1194B1 | Aneurysm Retractor 7mm |
| M268438A1192B1 | Aneurysm Retractor 3mm |
| M268A10401 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1154D1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1154B1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1077E1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1077C1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268438A1077A1 | The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the op |
| M268S443A1070B1 | Titanium Retractor Arm Assembly – 12 Inch (300 mm) |
| M268S443A10041 | Radiolucent Halo Wrench |
| M268S443A10001 | Radiolucent Halo Ring Assy |
| M268443A1070C1 | Titanium Retractor Arm Assembly – 6 Inch (150 mm) |
| M268443A1070B1 | Titanium Retractor Arm Assembly – 12 Inch (300 mm) |
| M268438A11601 | BUDDE® Halo 6” Retractor Arm |
| M268S443A1070C1 | Titanium Retractor Arm Assembly – 6 Inch (150 mm) |
| M268S443A1070A1 | Titanium Retractor Arm Assy – 9 Inch (225 mm) |
| M268S443A1061A1 | BUDDE® Halo 6 inch (150 mm) Flex Arm |
| M268S443A10601 | BUDDE® Halo Rod Support Clamp Assembly |
| M268S438B10101 | BUDDE® Support Bracket Assembly |
| M268S438A1200A1 | SAMY™ Vascular Retractor Blade – Short 3.6” |
| M268S438A11881 | BUDDE® Halo 12” Support Rod (5/16”) |
| M268S438A11401 | BUDDE® Halo Mini Vise |
| M268S438A11141 | BUDDE® Halo Grooved Rod |
| M268S438A11081 | BUDDE® Halo Adjustment Bar |
| M268S438A10371 | BUDDE® Halo Pattie Tray |
| M268S438A10241 | BUDDE® Halo Adjustment Wrench |
| M268S443B10521 | Radiolucent Halo Support Rod |
| M268S443A1012A1 | BUDDE® Halo 12 inch (300 mm) Flex Arm |
| M268S438A1200B1 | SAMY™ Vascular Retractor Blade – Long 4.6" |
Trademark Results [BUDDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BUDDE 74174710 1717845 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 1991-06-10 |
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