SOURCE SURGICAL INC. 68-3230-B

GUDID 84895237141471

Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

KENPAX INTERNATIONAL LIMITED

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Primary Device ID84895237141471
NIH Device Record Keycf8ea941-f2b2-437b-96ef-ee1ff5803aeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOURCE SURGICAL INC.
Version Model Number1
Catalog Number68-3230-B
Company DUNS686206765
Company NameKENPAX INTERNATIONAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS174895237141474 [Primary]
GS184895237141471 [Package]
Contains: 74895237141474
Package: case [400 Units]
In Commercial Distribution

FDA Product Code

FXPCover, Shoe, Operating-Room

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-23
Device Publish Date2021-03-15

On-Brand Devices [SOURCE SURGICAL INC.]

84895237141471Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physi
84895237141464Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff
84895237141457Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff

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