JohnMark International, Inc.

Basic Information

• Brand Name: JohnMark International, Inc.
• Primary DI: 00850011148020
• Version / Model: JMI-SBTD-EYE-0002
• Catalog Number: SBTD-EYE-0002
• Company Name: JOHNMARK INTERNATIONAL, INC
• Labeler DUNS: 095389457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-20
• Public Version: 2
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: e38e6542-38b1-4224-bb61-f2b28f2ae3fb

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850011148027	GS1	Case	20	In Commercial Distribution
Primary	00850011148020	GS1