Custom Healthcare Systems Inc.

GUDID 20811870035207

CUSTOM HEALTHCARE SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID20811870035207
NIH Device Record Keya6f0f859-5062-4bdb-83b8-c511a353641a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Healthcare Systems Inc.
Version Model NumberA3-7696
Company DUNS175254820
Company NameCUSTOM HEALTHCARE SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811870035203 [Primary]
GS120811870035207 [Package]
Contains: 00811870035203
Package: N/A [20 Units]
In Commercial Distribution

FDA Product Code

KXGApplicator, Absorbent Tipped, Sterile

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


[20811870035207]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-27
Device Publish Date2018-07-27

On-Brand Devices [Custom Healthcare Systems Inc.]

20811870035849D36-15961
20811870035726B9-17799D
20811870035719B9-18944
20811870035610UVA-17915
20811870035603R1542
20811870035597B9-16938
20811870035511YM-18918
20811870035504UNC-18917
20811870035481B9-18914
20811870035283D6-11243
20811870035245UNC-18963
20811870035238A3-7954
20811870035221B9-18339
20811870035207A3-7696
208118700351916873011
20811870035177D10-10698
20811870035146D8-9560B
20811870035115D36-18880
20811870035016D8-9425B
20811870034965B9-18863
20811870034958D6-15955
20811870034934BGI-18792
20811870034859B9-18847
20811870034835B9-18826
20811870034828B9-18825
20811870034804CDWS-18821
20811870034712B9-18815
20811870034705B9-18814
20811870034699POK-18818
20811870034637D36-18794
20811870034620D20-15443LF
20811870034613D20-11278LF
208118700346063404253A
20811870034538R1667
208118700345145026CL-13
20811870034477R1112B
20811870034446S1528H
20811870034415VBS-18520B
20811870034217D363025A
20811870034132MWM-18364C
20811870034125CDWS-18374B
20811870034033ZZ-0956
20811870034026ZZ-0958
20811870033951B9-16999B
20811870033920CJD-16914
20811870033838MANN-18617
20811870033807ZZ-0960
20811870033739B9-11260
20811870033654D14-32C
20811870033616D36-16229

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