FDA.reportPublic FDA data

iFIX

Primary DI
09010279000107
Brand
iFIX
Company
iSYS Medizintechnik GmbH
Model
Fleece 5
Catalog number
31618
Device description
short-term patient stabilization device
Published
2019-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010279000107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010279000107090102790001079010279000107

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s) or band(s), intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Meter
Width50Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300207996
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09010279001548Micromate Navi+iONE2024-02-26
09010279000411MicromateiONE2023-09-06
09010279001708iFIXiFIX Side Rail Adapter US42642-US2024-07-30
09010279001715iFIXiFIX Side Rail Adapter JP42642-JP2024-07-30
09010279001050iFIXiFIX Arm Rest Tray558072024-07-30
09010279001289iFIXiFIX Canon Aquilion Adapter546312024-07-30
29010279001702iFIXiFIX Side Rail Adapter US42642-US2024-07-30
29010279001719iFIXiFIX Side Rail Adapter JP42642-JP2024-07-30
09010279001142iFIXHead Kit MRI GE587812021-07-01
09010279001128iFIXHead Kit Angio587792021-07-01
09010279001135iFIXHead Kit CT587802021-07-01
09010279001159iFIXThorax Kit CT Canon587872021-07-01
09010279001166iFIXThorax Kit CT Siemens587882021-07-01
09010279001173iFIXKit CT Micromate BP587862021-07-01
09010279001180iFIXThorax Kit CT GE587892021-07-01
09010279001197iFIXThorax Kit MRI Philips587912021-07-01
09010279001203iFIXThorax Kit MRI Siemens587922021-07-01
09010279001210iFIXThorax Kit MRI GE587932021-07-01
09010279001227iFIXArm Stabilization Kit587962021-07-01
09010279001234iFIXSpine Surgery Kit587982021-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
10748426141125Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
09010279001708iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
10190676003232POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003348POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003355POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005441POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005458POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005465POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676001016POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001085POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001108POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002518POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002525POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002532POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002549POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002563POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002617POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05