iFIX 31618

GUDID 09010279000107

short-term patient stabilization device

iSYS Medizintechnik GmbH

Limb/torso/head restraint, single-use

• Primary Device ID: 09010279000107
• NIH Device Record Key: 1cdf3c8a-55dd-43f1-9c17-2a921ea7fe01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFIX
• Version Model Number: Fleece 5
• Catalog Number: 31618
• Company DUNS: 300207996
• Company Name: iSYS Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter
• Length: 30 Meter
• Width: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09010279000107 [Primary]

FDA Product Code

• FMQ: Restraint, Protective

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-31

On-Brand Devices [iFIX]

• 49010279000211: Short-term patient stabilization device
• 49010279000198: short-term patient stabilization device
• 29010279000187: short-term patient stabilization device
• 29010279000170: short-term patient stabilization device
• 29010279000163: short-term patient stabilization device
• 29010279000156: short-term patient stabilization device
• 29010279000149: short-term patient stabilization device
• 29010279000132: short-term patient stabilization device
• 49010279000099: short-term patient stabilization device
• 49010279000082: short-term patient stabilization device
• 49010279000075: short-term patient stabilization device
• 49010279000068: short-term patient stabilization device
• 49010279000051: short-term patient stabilization device
• 49010279000044: short-term patient stabilization device
• 49010279000037: short-term patient stabilization device
• 29010279000026: short-term patient stabilization device
• 49010279000013: short-term patient stabilization device
• 09010279000121: short-term patient stabilization device
• 09010279000114: short-term patient stabilization device
• 09010279000107: short-term patient stabilization device
• 49010279000426: short-term patient stabilization device
• 09010279000602: Short-term patient stabilization device
• 09010279000596: Short-term patient stabilization device
• 09010279000497: Short-term patient stabilization device
• 09010279000480: Short-term patient stabilization device
• 09010279000473: Short-term patient stabilization device
• 09010279000466: Short-term patient stabilization device
• 09010279000459: Short-term patient stabilization device
• 09010279000442: short-term patient stabilization device
• 09010279001241: short-term patient stabilization
• 09010279001234: short-term patient stabilization
• 09010279001227: short-term patient stabilization
• 09010279001210: short-term patient stabilization
• 09010279001203: short-term patient stabilization
• 09010279001197: short-term patient stabilization
• 09010279001180: short-term patient stabilization
• 09010279001173: short-term patient stabilization
• 09010279001166: short-term patient stabilization
• 09010279001159: short-term patient stabilization
• 09010279001142: short-term patient stabilization
• 09010279001135: short-term patient stabilization
• 09010279001128: short-term patient stabilization
• 29010279001719: Designed for connection with operating tables, contains a side-rail adapter portion (to fit JP s
• 29010279001702: Designed for connection with operating tables, contains a side-rail adapter portion (to fit US s
• 09010279001289: The iFIX Canon Aquilioin Adapter is a non-sterile product which allows to attach a Slot Adapter
• 09010279001050: iFIX Tray is a extremity support product, a part of iFIX Arm Rest. It is a long top surface capa