FDA.reportPublic FDA data

SPY PAQ

Primary DI
10858701006268
Brand
SPY PAQ
Company
Novadaq Technologies Inc
Model
LC3006
Catalog number
LC3006
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZISystem, x-ray, angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182907000SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2019-01-23IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20858701006265PackageGS16In Commercial Distribution
10858701006268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085870100626520858701006265
1085870100626810858701006268

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
243730939
Device count
1
Kit
true
Lot or batch
true
Expiration 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
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
20858701006258SPY®ND30102017-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixIZI2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
00195278719263AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719577AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719720AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719744AlliaGE MEDICAL SYSTEMSIZI2023-12-08
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10841962118733Iris AirShuttle™QfixIZI2023-04-10
00195278485144AlliaGE MEDICAL SYSTEMSIZI2022-04-13
00195278485168AlliaGE MEDICAL SYSTEMSIZI2022-04-08
00860001790290SterimedSTERIMED LLCIZI2021-09-29
00860007655609SterimedSTERIMED LLCIZI2021-09-29
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059458NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
20193489066927NAMICMEDLINE INDUSTRIES, INC.IZI2021-05-12
00195278215543AlliaGE MEDICAL SYSTEMSIZI2021-03-31
00195278215550AlliaGE MEDICAL SYSTEMSIZI2021-03-31
10858701006213SPYNovadaq Technologies IncIZI2020-09-21
00860001790214SterimedSTERIMED LLCIZI2020-04-27
00810116023011Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00810116023028Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00840682147378INNOVAGE MEDICAL SYSTEMSIZI2020-02-03