AccessGUDID - DEVICE: Sterile Narrow Polyester Spun Swab (00860004112723)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Narrow Polyester Spun Swab
Version or Model: 60567
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Steripack (usa) Limited LLC

Primary DI Number: 00860004112723
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2000
Labeler D-U-N-S® Number*: 042126640 *Terms of Use

Device Description: single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares

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:	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?
54970	Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-Hu antibodies in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXG	Applicator, Absorbent Tipped, Sterile

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: Yes

Sterilization Method [?]
Radiation Sterilization

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: 449effc0-ba43-4701-8429-9f1ac3a95d06
Public Version Date: October 11, 2022
Public Version Number: 1
DI Record Publish Date: October 03, 2022