FDA.report

McKesson

Primary DI
40612479159752
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
73-GT036
Device description
TAPE, INDICATOR EO GAS 1"
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications

CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479159752PrimaryGS10
10612479219547Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247915975240612479159752
1061247921954710612479219547

GMDN Terms

TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
18
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
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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