JohnMark International, Inc.

Primary DI
10850011148010
Brand
JohnMark International, Inc.
Company
JOHNMARK INTERNATIONAL, INC
Model
JMI-SBTD-UNI0001
Catalog number
SBTD-UNI0001
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.
Published
2019-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850011148010PackageGS120In Commercial Distribution
00850011148013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001114801010850011148010
00850011148013008500111480138500111480130850011148013

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
095389457
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011148013JohnMark International, Inc.JMI-SBTD-UNI0001SBTD-UNI00012019-08-20
00850011148020JohnMark International, Inc.JMI-SBTD-EYE-0002SBTD-EYE-00022019-08-20
10850011148027JohnMark International, Inc.JMI-SBTD-EYE-0002SBTD-EYE-00022019-08-20

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Primary DI, Brand, Company table
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