CUSTOM HEALTHCARE SYSTEMS, INC

GUDID 20811870034064

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 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 ID20811870034064
NIH Device Record Key2b7a33a9-4336-4ecf-a10a-9243deb4c818
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUSTOM HEALTHCARE SYSTEMS, INC
Version Model NumberB9-19629
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
GS100811870034060 [Primary]
GS120811870034064 [Package]
Contains: 00811870034060
Package: N/A [40 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


[20811870034064]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-12
Device Publish Date2019-12-04

On-Brand Devices [CUSTOM HEALTHCARE SYSTEMS, INC]

2081187003222094-59041-C
20811870033166YMCP-TCRS02
20811870032800L1000-19275
2081187003318084RN0107-B
20811870032947DT-052019
20811870034545L1000-19316
20811870033289SK-11489
20811870033272PAK-19245
20811870033265PAK-19244
20811870033685KM-19370-1
20811870033692B9-19473
20811870033708R1903
00811870033742UNC-19544
20811870033760JPK-19558
20811870033753JPK-19560
20811870033791KM-19382
20811870033944MWM-19224
20811870034118KM3405353
20811870034101KM3403356
20811870034095KM3405432
20811870034088KM3405251
20811870034002KM5071
20811870033999KM5072
20811870033982KM5073
20811870033975KM5074
20811870033968KM5075
20811870034040M100-19608
20811870034064B9-19629
20811870034057D40-11262
20811870034149D6-19461
20811870034187SJ-19320
20811870034170SJ-19319
20811870034163SJ-19318
20811870034224KM1722-01
00811870034275B9-19702
20811870034262B9-19701
20811870034255B9-19704
20811870034248B9-19703
00811870034336NINE006
20811870034323NINE003
20811870034316NINE001
20811870034422YMSEC-188C
20811870034392SUM009-00
20811870034385SUM008-00
20811870034378NINE009
20811870034361NINE007
00811870034350NINE005
20811870034347NINE004
20811870034309B9-15064
20811870034453NINE002

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