AccessGUDID - DEVICE: McKesson (00612479105720)

GUDID

Device Identifier (DI) Information

Brand Name: McKesson
Version or Model: 24-807
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MCKESSON MEDICAL-SURGICAL INC.

Primary DI Number: 00612479105720
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 023904428 *Terms of Use

Device Description: Applicator Stick McKesson Without Tip Wood Shaft 6 Inch NonSterile 1000 per Pack

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:	Yes
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?
33954	Cotton pledget applicator, single-use	A slender rod of wood, flexible metal, or synthetic material with a pledget of cotton attached at one end intended to be used for cleaning or applying a substance (e.g., medication) to superficial wounds or body orifices [e.g., ears, nose, oral cavity, throat, anus, rectum]. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KCJ	Applicator, Ent

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: 0fdfcc42-35cf-4773-af9c-012e90c6275a
Public Version Date: December 07, 2018
Public Version Number: 2
DI Record Publish Date: October 05, 2018