CUSTOM HEALTHCARE SYSTEMS INC

GUDID 20811870031001

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 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: 20811870031001
• NIH Device Record Key: eb10f62e-3b5d-4c5d-b82b-ae52b7999620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSTOM HEALTHCARE SYSTEMS INC
• Version Model Number: R1676
• Company DUNS: 175254820
• Company Name: CUSTOM HEALTHCARE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811870031007 [Primary]
GS1	20811870031001 [Package]; Contains: 00811870031007; Package: N/A [10 Units]; In Commercial Distribution

FDA Product Code

• OKV: Obstetrical Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-09-14
• Device Publish Date: 2018-07-25

On-Brand Devices [CUSTOM HEALTHCARE SYSTEMS INC]

• 20811870035467: 83-0016
• 20811870034156: D21-9064
• 20811870034071: NAC001-02
• 20811870033487: 0503A
• 20811870032954: B9-17798
• 00811870032882: D36-6002BB
• 20811870032510: B9-17197
• 20811870032275: B9-16951-3
• 20811870032077: 38803016
• 20811870031995: B9-16951-2
• 00811870031830: B9-16261
• 20811870031728: B9-18948
• 20811870031674: MWM-18937
• 00811870031519: D24-8492
• 20811870031483: UNC-9471
• 20811870031407: B9-16705
• 20811870031384: BMET-19019
• 20811870031353: COMBO-17891
• 20811870031124: B9-17244
• 20811870031001: R1676
• 00811870030963: R1178
• 20811870030714: B9-18339B
• 20811870030561: 83-0011
• 00811870030468: B9-18985
• 20811870035313: S1528C
• 20811870035047: UVA-19219
• 20811870032329: B9-19168
• 20811870035627: CHC-2155
• 20811870032589: JPK-19181
• 20811870032367: L2000-19173