FDA.reportPublic FDA data

NOVADAQ®and PINPOINT®

Primary DI
00858701006148
Brand
NOVADAQ®and PINPOINT®
Company
Novadaq Technologies Inc
Model
PC9017
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858701006148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858701006148008587010061488587010061480858701006148

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243730939
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858701006568PINPOINTPC9004PC90042018-12-12
00858701006025SPYLC3000LC30002016-09-23
00858701006032LUNALU3000LU30002016-09-23
00858701006551PINPOINTPC9002PC90022018-12-12
10858701006251SPY®ND30102017-01-30
10858701006329SPY-PHI SystemHH20002017-03-31
10858701006299NOVADRAPE®ND80002018-01-08
10858701006268SPY PAQLC3006LC30062016-09-23
10858701006282SPY-PHI SystemHH9001HH90062017-03-31
10858701006176PINPOINT PAQPP9031PP90362016-09-23
20858701006326SPY-PHI SystemHH20002017-03-31
00858701006049NOVADAQ and PINPOINTPC9000PC90012016-09-23
00858701006056NOVADAQ and PINPOINTSC9104SC91042016-09-23
00858701006063NOVADAQ and PINPOINTSC9134SC91342016-09-23
00858701006070NOVADAQ and PINPOINTSC9144SC91442016-09-23
00858701006124NOVADAQ and PINPOINTSC9504SC95042016-09-23
00858701006131NOVADAQ and PINPOINTSC9534SC95342016-09-23
00858701006193SPY-PHI SystemHH9000HH90302017-03-31
00858701006209NOVADAQ and PINPOINTSC9544SC95442016-09-23
10858701006220PINPOINT PAQ® PP90922016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015090PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015106PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942012990PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013003PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013010PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013027PRIMEDpriMED Medical Products IncFRG2026-05-29
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