FDA.report

Dental City

Primary DI
D771604230
Brand
Dental City
Company
ICP, INC.
Model
60-423
Device description
Dental City Sterilization Pouches 5.25x10 200/Box
Published
2021-06-25
Public version status
New
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
D77160423PrimaryHIBCC0
D771604230Unit of UseHIBCC0

GMDN Terms

TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
808371371
Device count
200
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

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D7717270031Dental City72-70032026-05-26
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D7717270091Dental City72-70092026-05-26
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D7717271081Dental City72-71082026-05-26
D7717271141Dental City72-71142026-05-26
D7717272041Dental City72-72042026-05-26
D7717272051Dental City72-72052026-05-26
D7717272061Dental City72-72062026-05-26
D7717272141Dental City72-72142026-05-26
D7717272741Dental City72-72742026-05-26
D7717273031Dental City72-73032026-05-26
D7717273041Dental City72-73042026-05-26
D7717273771Dental City72-73772026-05-26
D7717273781Dental City72-73782026-05-26

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