Custom Healthcare Systems of Virginia

GUDID 20811870035290

CUSTOM HEALTHCARE SYSTEMS, INC.

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID20811870035290
NIH Device Record Keyc264107c-c5b1-4a0d-ae00-5c5a1aa98669
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Healthcare Systems of Virginia
Version Model NumberKM-19871
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 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
GS100811870035296 [Primary]
GS120811870035290 [Package]
Contains: 00811870035296
Package: NA [20 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

[20811870035290]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-22
Device Publish Date2021-03-12

On-Brand Devices [Custom Healthcare Systems of Virginia]

20811870035658L1000-19706
20811870037362D36-7531
20811870035252UNC-14685A
20811870035955L2000-19933
20811870035269UNC-19952
20811870035290KM-19871
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