BUDDE®
GUDID M268S438A1200B1
SAMY™ Vascular Retractor Blade – Long 4.6"
INTEGRA LIFESCIENCES CORPORATION
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" |
| 10381780542339 | BUDDE® Halo 6” Retractor Arm |
| 10381780538271 | Integra® ANEURYSM RETRACTOR 5MM X 6 5 LNG |
| 10381780538097 | Budde® Halo Retractor Side Rail Support |
| 10381780538080 | Titanium Retractor Arm Assembly – 6 Inch (150 mm) |
| 10381780538073 | Titanium Retractor Arm Assembly – 12 Inch (300 mm) |
| 10381780255871 | Integra® ANEURYSM RETRACTOR 7MM X 6.5 LNG |
| 10381780538059 | Integra® ANEURYSM RETRACTOR 7MM X 5.5 LNG |
| 10381780255857 | Integra® ANEURYSM RETRACTOR 3MM X 6.5 LNG |
| 10381780538035 | Integra® ANEURYSM RETRACTOR 3MM X 5.50 |
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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