AccessGUDID - DEVICE: Spencer (08057711232239)

GUDID

Device Identifier (DI) Information

Brand Name: Spencer
Version or Model: ST36456B C-MAXFIXING SYSTEM CERTIFIED 10G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPENCER ITALIA SRL

Primary DI Number: 08057711232239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 442102067 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
31134	Assistive automobile wheelchair fastener	A device intended to be used in a motor vehicle, e.g., a car or van, which is built or adapted for use by a person with a disability. It is designed to restrain a wheelchair, usually occupied, in a secured locked position during the journey in the vehicle. This device is typically anchored to the vehicle floor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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
No Device Sizes

Device Record Status

Public Device Record Key: a38998a0-bd1d-46b6-9ca3-50fd2f119578
Public Version Date: December 15, 2023
Public Version Number: 1
DI Record Publish Date: December 07, 2023