JohnMark International, Inc. SBTD-UNI0001

GUDID 10850011148010

Mapped sterile single-use surgical back table drape which provides specific assigned delineated areas clearly marked for specific surgical items to facilitate a standardized uniform setup, order and management of the surgical back table to facilitate efficiency, instant counts and accountability of surgical instruments and items placed on the back table. Device also facilitates in training surgical technicians, scrub nurses and any surgical assist personnel to learn and adapt to a standardized methodology of surgical procedure set up and management of surgical instruments and items facilitating more efficiency, safety and positive patient outcomes.

JOHNMARK INTERNATIONAL, INC

Medical equipment drape, single-use

• Primary Device ID: 10850011148010
• NIH Device Record Key: 7cfba5a4-6498-42fb-9946-f6536d667357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JohnMark International, Inc.
• Version Model Number: JMI-SBTD-UNI0001
• Catalog Number: SBTD-UNI0001
• Company DUNS: 095389457
• Company Name: JOHNMARK INTERNATIONAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011148013 [Primary]
GS1	10850011148010 [Package]; Contains: 00850011148013; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-08-20

On-Brand Devices [JohnMark International, Inc.]

• 10850011148027: Mapped sterile single-use surgical back table drape which provides specific assigned delineated
• 10850011148010: Mapped sterile single-use surgical back table drape which provides specific assigned delineated