InfraVision

Primary DI
37613327061216
Brand
InfraVision
Company
STRYKER CORPORATION
Model
0220180517
Catalog number
0220180517
Device description
[Universal Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 200 cm Length, Do not u
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCSLight, catheter, fiberoptic, glass, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCSLight, Catheter, Fiberoptic, Glass, UreteralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061548000STRYKER URETERAL ILLUMINATION SYSTEM IVStryker Corp.2006-09-28FCS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327061216PackageGS15In Commercial Distribution
07613327061215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332706121637613327061216
07613327061215076133270612157613327061215

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551169629n.a.Karl Storz GmbH & Co. KGFCS2018-08-24
04048551253687n.a.Karl Storz GmbH & Co. KGFCS2017-10-21
00827002161436BushCOOK INCORPORATEDFCS2016-09-24
00827002162624BushCOOK INCORPORATEDFCS2016-09-24
00827002167377BushCOOK INCORPORATEDFCS2016-09-24
00827002167452BushCOOK INCORPORATEDFCS2016-09-24
00827002167469BushCOOK INCORPORATEDFCS2016-09-24
00827002167476BushCOOK INCORPORATEDFCS2016-09-24
07613327061215InfraVisionSTRYKER CORPORATIONFCS2016-09-23
07613327174816IRISSTRYKER CORPORATIONFCS2016-09-23