FDA.report

McKesson

Primary DI
40612479232103
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
183-40-3630-S
Device description
Banded Bag CLEAR PE FILM STERILE 36 in x 30 in
Published
2019-06-11
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

Related Records

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479232103PackageGS150In Commercial Distribution
10612479232096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247923210340612479232103
1061247923209610612479232096

GMDN Terms

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

Regulatory Flags

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00612479282179McKesson16-4839-22026-03-17
00612479124448McKesson16-71312026-03-11
00612479124455McKesson16-71322026-03-11
00612479124462McKesson16-71332026-03-11
00612479135468McKesson16-71352026-03-11
00612479135512McKesson16-71362026-03-11
00612479160651McKesson70-101PMCK2026-03-11
00612479160668McKesson70-105PMCK2026-03-11
00612479160675McKesson70-109PMCK2026-03-11
00612479185388McKesson70-1121MCK2026-03-11
00612479185395McKesson70-1122MCK2026-03-11
40612479280920McKesson16-1000-PMBL2026-02-26
40612479262162McKesson18-3300M2026-02-23
10612479275932McKesson91-31052026-02-20
10612479281575McKesson181-342252026-02-06
10612479281582McKesson181-342252026-02-06
00612479278356McKesson16-61442026-01-26
00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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