AccessGUDID - DEVICE: Sannio Mesh (00860006225025)

GUDID

Device Identifier (DI) Information

Brand Name: Sannio Mesh
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Sannio Group Inc

Primary DI Number: 00860006225025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 117795806 *Terms of Use

Device Description: This mesh, uses the Aeovis device as a framework, together suspending a patient's arm while laying in a hospital bed. The mesh is a disposable product and should be changed frequently.

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:	Yes
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?
46325	Elevation arm sling	A non-sterile hanging band intended to immobilize an injured arm, that is typically suspended from an overhead support. It is designed to elevate the extremity to aid in controlling oedema, enhancing recovery typically following hand or forearm surgery. This is a single-use 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: 3840803b-050e-4073-b8ec-318c5f5687eb
Public Version Date: February 10, 2021
Public Version Number: 1
DI Record Publish Date: February 02, 2021