AccessGUDID - DEVICE: iFIX (09010279000114)

GUDID

Device Identifier (DI) Information

Brand Name: iFIX
Version or Model: Fleece 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16304
Company Name: iSYS Medizintechnik GmbH

Primary DI Number: 09010279000114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300207996 *Terms of Use

Device Description: short-term patient stabilization device

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, 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 while potentially permitting limited movement. 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMQ	Restraint, Protective

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 200 Meter
Width: 150 Millimeter

Device Record Status

Public Device Record Key: 20994e10-73bf-4bd5-b0ea-6b9a20fd4610
Public Version Date: November 06, 2020
Public Version Number: 2
DI Record Publish Date: March 31, 2019