AccessGUDID - DEVICE: ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS (00733657290684)

GUDID

Device Identifier (DI) Information

Brand Name: ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS
Version or Model: 3171603
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALIMED, INC.

Primary DI Number: 00733657290684
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 056007248 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
66493	Pilates reformer exerciser	A non-powered, whole-body exercise apparatus intended primarily to strengthen and improve flexibility of the core, lower body, and upper body muscle groups, and to improve posture and range of motion, through repetitive movements against spring resistance. It consists of a floor-standing frame with a sliding sled/platform upon which the user stands, sits, kneels or lies, and adjustable ropes, loops/handles, rollers, anchoring bars, and springs of various resistances. This device is designed for therapeutic programs in physiotherapy, rehabilitation, sports therapy, prevention, functional fitness, and recreational sports.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	EXERCISER, NON-MEASURING

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: b9c53d23-0458-4730-b243-a7049bdc1172
Public Version Date: February 26, 2024
Public Version Number: 3
DI Record Publish Date: December 01, 2022