AccessGUDID - DEVICE: MEDLINE (10193489190847)

GUDID

Device Identifier (DI) Information

Brand Name: MEDLINE
Version or Model: DYNDA2723
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYNDA2723
Company Name: CENTURION MEDICAL PRODUCTS CORPORATION

Primary DI Number: 10193489190847
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017246562 *Terms of Use

Device Description: SWABSTICKS ALCOHOL 3PK

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):	Yes
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?
13913	Antiseptic skin swab	A device that is pre-soaked with an antiseptic and intended to inhibit the growth of microorganisms on the skin; it may also include an anaesthetic to alleviate pain. It is typically designed as a sterile cotton swab (a pledget) on a plastic stick and used in the hospital environment, in the home, or carried for first aid to prevent infection and provide temporary pain and itching relief associated with minor cuts, scrapes, or burns. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKB	Pad, alcohol, device disinfectant

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: Yes
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: 6347361f-147a-45d0-8659-0b4c263b340e
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: April 24, 2020