FDA.reportPublic FDA data

PINPOINT

Primary DI
00858701006568
Brand
PINPOINT
Company
Novadaq Technologies Inc
Model
PC9004
Catalog number
PC9004
Device description
Light Guide Cable
Published
2018-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150956000PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016-05-23GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858701006568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858701006568008587010065688587010065680858701006568

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(604)232-9861xx@xx.com

Regulatory Flags#

DUNS number
243730939
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858701006049NOVADAQ and PINPOINTPC9000PC90012016-09-23
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
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
20858701006258SPY®ND30102017-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28