Swabeze KMI-65

GUDID 20817522013357

foam swab

KENTEC MEDICAL, INC.

General-purpose absorbent tip applicator/swab, single-use
Primary Device ID20817522013357
NIH Device Record Keyb97814ab-3fa4-4a09-aefc-723495b60849
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwabeze
Version Model NumberKMI-65
Catalog NumberKMI-65
Company DUNS066175613
Company NameKENTEC MEDICAL, INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817522013353 [Primary]
GS110817522013350 [Unit of Use]
GS120817522013357 [Package]
Contains: 00817522013353
Package: box [300 Units]
In Commercial Distribution
GS130817522013354 [Package]
Package: case [33600 Units]
In Commercial Distribution

FDA Product Code

KXFApplicator, Absorbent Tipped, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-05
Device Publish Date2024-06-27

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