Setmark Inc.

GUDID 00854204008603

SETMARK INC.

General-purpose stool/chair

• Primary Device ID: 00854204008603
• NIH Device Record Key: 92c42f8e-a0b9-48b6-ba96-493afe9fa78d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Setmark Inc.
• Version Model Number: DC-108
• Company DUNS: 080798558
• Company Name: SETMARK INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854204008603 [Primary]

FDA Product Code

• FZM: Stool, Operating-Room

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-29
• Device Publish Date: 2024-04-21

On-Brand Devices [Setmark Inc.]

• 00854204008597: Cut - off Hydraulic stretcher, includes O2 tank & IV pole - Non Ferrous.NF-300
• 00854204008603: DC-108