CUSTOM HEALTHCARE SYSTEMS, INC

GUDID 20811870034040

CUSTOM HEALTHCARE SYSTEMS, INC.

General surgical procedure kit, medicated
Primary Device ID20811870034040
NIH Device Record Key8747dd1d-3521-42fd-bc2e-7c050de7520a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUSTOM HEALTHCARE SYSTEMS, INC
Version Model NumberM100-19608
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
GS100811870034046 [Primary]
GS120811870034040 [Package]
Contains: 00811870034046
Package: N/A [5 Units]
In Commercial Distribution

FDA Product Code

OEZCardiovascular Procedure Kit

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870034040]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

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

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