AccessGUDID - DEVICE: MedibinoNEO disposable cover cotton knit WITH soft granules - Size L

GUDID

Device Identifier (DI) Information

Brand Name: MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31021703-L
Company Name: Kluba Medical GmbH

Primary DI Number: 04260764840670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 313383362 *Terms of Use

Device Description: The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have a cenral inner filling with soft granules and are fitting for the MedibinoNeo ring size L

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
44294	Infant recumbent sleep positioner	A non-rigid device, usually made of flame retardant fabric and/or polyurethane foam materials, intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly, a flattening of the back of the skull from a consistent back-sleeping position. It is available in a variety of designs including a wedge-shaped head pillow, a sleeping garment (sleeveless vest) with hooks/Velcro fasteners/nylon zip fasteners and an insertable foam wedge, or a specially designed mattress. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PRN	Pediatric Position Holder
FRP	Holder, Infant Position
FMP	Protector, Skin Pressure

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
Device Size Text, specify: Accessory fitting for MedibinoNeo gel rings Size L

Device Record Status

Public Device Record Key: 408ff9fe-3c8d-43f1-87bf-1319f85c0c77
Public Version Date: September 16, 2024
Public Version Number: 1
DI Record Publish Date: September 06, 2024