Custom Assemblies, Inc.

GUDID 00815849023437

Procedure Kit

CUSTOM ASSEMBLIES, INC.

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 ID00815849023437
NIH Device Record Key123dc72a-fc4a-4c22-b6b5-f6741960efa5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Assemblies, Inc.
Version Model NumberCMS-2012-R3
Company DUNS948904735
Company NameCUSTOM ASSEMBLIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815849023437 [Primary]

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-21
Device Publish Date2023-09-13

On-Brand Devices [Custom Assemblies, Inc. ]

00815849023444Procedure Kit
00815849023437Procedure Kit

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