AccessGUDID - DEVICE: ManaMed (00810113680170)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: Bionic Sling Air Shoulder
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BS001
Company Name: Manamed, Inc.

Primary DI Number: 00810113680170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The Bionic Sling is a universal shoulder sling with a continuous passive machine to promote small movements after shoulder surgeries to help patients recover quicker. Features and Benefits Universal sizing and can be applied to the left or right side Breathable material for patient comfort Provides support for shoulder surgeries or conservative care of shoulder injuries Passive Machine The pneumatic passive machine included with the shoulder sling To be worn to promote abduction movement with internal and external rotation Ability to achieve various abduction angles from 30 to 90 degrees The machine is portable, wireless, and rechargeable Common Examples of Use To promote small movements after rotator cuff, arthroscopic, and anterior repairs To prevent frozen shoulder Shoulder instabilities To be worn to eliminate the need for contracture braces

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):	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?
12101	Shoulder immobilizer/orthosis, reusable	A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILI	Sling, Arm

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: be98544b-03c8-44d7-a719-750165e34718
Public Version Date: July 11, 2024
Public Version Number: 2
DI Record Publish Date: June 20, 2022