AccessGUDID - DEVICE: Drive (00822383546667)

GUDID

Device Identifier (DI) Information

Brand Name: Drive
Version or Model: PAN-RCHR-32
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383546667
Issuing Agency: GS1
Commercial Distribution End Date: February 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: DS Reacher 32", 1RTL/Box, 12box/case

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?
30096	Assistive manual gripping tongs	A manually-operated device intended to be used by a person with a disability to lengthen (extend) their normal reach to enable them to reach, grasp, and pick-up objects at a distance.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILD	ADAPTOR, DRESSING

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: c76c244b-42e3-40ef-bd24-0b47370394c4
Public Version Date: March 01, 2024
Public Version Number: 3
DI Record Publish Date: July 10, 2017