Duns Number:095389457
Device Description: Mapped sterile single-use surgical back table drape which provides specific assigned delin 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.
Catalog Number
SBTD-UNI0001
Brand Name
JohnMark International, Inc.
Version/Model Number
JMI-SBTD-UNI0001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
7cfba5a4-6498-42fb-9946-f6536d667357
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
August 20, 2019
Package DI Number
10850011148010
Quantity per Package
20
Contains DI Package
00850011148013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |