Custom Healthcare Systems, Inc.

GUDID 20811870036341

CUSTOM HEALTHCARE SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use
Primary Device ID20811870036341
NIH Device Record Key1775459c-4a77-4192-b0c0-7b376d2f2153
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Healthcare Systems, Inc.
Version Model NumberB9-16938A
Company DUNS175254820
Company NameCUSTOM HEALTHCARE SYSTEMS, INC.
Device Count1
DM Exempttrue
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 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
GS100811870036347 [Primary]
GS120811870036341 [Package]
Contains: 00811870036347
Package: NA [12 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870036341]

Ethylene Oxide

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[20811870036341]

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[20811870036341]

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[20811870036341]

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Ethylene Oxide

[20811870036341]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

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[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-22
Device Publish Date2020-09-14

On-Brand Devices [Custom Healthcare Systems, Inc.]

20811870036310R1554
20811870036341B9-16938A
20811870036396KM3405353-2
20811870035931B9-19835
20811870035368D21-9064
20811870036235B9-15934C
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