CUSTOM HEALTHCARE SYSTEMS INC

GUDID 20811870035627

CUSTOM HEALTHCARE SYSTEMS, INC.

Surgical preparation kit
Primary Device ID20811870035627
NIH Device Record Key2d24becb-b178-41a8-9f79-b27622cef5fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUSTOM HEALTHCARE SYSTEMS INC
Version Model NumberCHC-2155
Company DUNS175254820
Company NameCUSTOM HEALTHCARE SYSTEMS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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
GS100811870035623 [Primary]
GS120811870035627 [Package]
Contains: 00811870035623
Package: N/A [10 Units]
In Commercial Distribution

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


[20811870035627]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2019-03-08

On-Brand Devices [CUSTOM HEALTHCARE SYSTEMS INC]

2081187003546783-0016
20811870034156D21-9064
20811870034071NAC001-02
208118700334870503A
20811870032954B9-17798
00811870032882D36-6002BB
20811870032510B9-17197
20811870032275B9-16951-3
2081187003207738803016
20811870031995B9-16951-2
00811870031830B9-16261
20811870031728B9-18948
20811870031674MWM-18937
00811870031519D24-8492
20811870031483UNC-9471
20811870031407B9-16705
20811870031384BMET-19019
20811870031353COMBO-17891
20811870031124B9-17244
20811870031001R1676
00811870030963R1178
20811870030714B9-18339B
2081187003056183-0011
00811870030468B9-18985
20811870035313S1528C
20811870035047UVA-19219
20811870032329B9-19168
20811870035627CHC-2155
20811870032589JPK-19181
20811870032367L2000-19173

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