AccessGUDID - DEVICE: De Mayo Adapt2Fit® Modular Knee Positioner (00696588007946)

GUDID

Device Identifier (DI) Information

Brand Name: De Mayo Adapt2Fit® Modular Knee Positioner
Version or Model: 706-A2 DEMO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 706-A2 DEMO
Company Name: Innovative Medical Products, Inc

Primary DI Number: 00696588007946
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 147363154 *Terms of Use

Device Description: Demo De Mayo Adapt2Fit® Modular Knee Positioner Sterilization Tray - 20" x 10" x 8"

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:	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?
62868	Medical capital equipment storage bag/case	A non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

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: 47291a0c-c6e5-4ed0-99f5-e26cb37af895
Public Version Date: April 24, 2025
Public Version Number: 1
DI Record Publish Date: April 16, 2025