Custom Healthcare Systems, Inc.

GUDID 20811870035368

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 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 ID	20811870035368
NIH Device Record Key	e9a6abe3-88ed-420e-b2ed-408738fc70cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Custom Healthcare Systems, Inc.
Version Model Number	D21-9064
Company DUNS	175254820
Company Name	CUSTOM HEALTHCARE SYSTEMS, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811870035364 [Primary]
GS1	20811870035368 [Package] Contains: 00811870035364 Package: NA [100 Units] In Commercial Distribution

FDA Product Code

FQM	Bandage, Elastic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

[20811870035368]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-12-08
Device Publish Date	2020-11-30

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

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