FDA.report

McKesson

Primary DI
40612479217346
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-1007
Device description
Non-Latex Probe Cover
Published
2017-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KKXDrape, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479217346PackageGS120In Commercial Distribution
20612479217335PrimaryGS10
10612479225920Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247921734640612479217346
2061247921733520612479217335
1061247922592010612479225920

GMDN Terms

TermDefinition
Body-orifice ultrasound imaging transducer cover, basic, non-sterileA non-sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
100
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
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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