FDA.reportPublic FDA data

UROLIFT

Primary DI
20814932020197
Brand
UROLIFT
Company
TELEFLEX INCORPORATED
Model
IPN056675
Catalog number
UL-RRKTRAY
Device description
UroLift System Rigid Retrieval Kit Sterilization Tray
Published
2022-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212396000UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc.2021-10-22KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20814932020197Direct MarkingGS10
10814932020190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081493202019720814932020197
1081493202019010814932020190

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(925)401-0700uroliftcustomer@teleflex.com

Regulatory Flags#

DUNS number
002348191
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222951ARROWCV-22703-ECV-22703-E2026-08-19
10801902222968ARROWCV-25703-ECV-25703-E2026-08-19
10801902222975ARROWCV-26702-ECV-26702-E2026-08-19
10801902222876ARROWCV-12122-FCV-12122-F2026-08-18
10801902222906ARROWCV-15122-UFCV-15122-UF2026-08-18
10801902225631ARROWIBAS-45563-CURVIBAS-45563-CURV2026-08-18
10841156108267TRAPLINERIPN91889355672026-08-18
14026704937452WECKEFXCT1EFXCT12026-08-18
14026704937469WECKEFXSP1EFXSP12026-08-18
14026704937476WECKEFX002EFX0022026-08-18
10801902124354ARROWIPN001121AA-006052016-09-16
10801902145496ARROWIPN039727SAC-01618-1A2019-07-29
10801902160734ARROWIPN915294AI-071212019-12-19
10801902161335ARROWIPN915831AI-071342020-01-27
10801902168846ARROWIPN916860CS-24701-E2022-11-29
10801902171402ARROWIPN917137CA-45703-P1A2022-02-16
10801902172508ARROWIPN917417CS-24306-E2022-11-29
10801902180268ARROWIPN917220AI-071212021-08-19
10801902180589ARROWIPN918510CS-12702-E2022-11-29
10801902180756ARROWIPN917232AI-071342021-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094016INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640094023INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640093972INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640093989INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640094009INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00724995239879V. MuellerSteris CorporationKCT2026-08-18
00724995239886V. MuellerSteris CorporationKCT2026-08-18
00724995239893V. MuellerSteris CorporationKCT2026-08-18
00724995240615V. MuellerSteris CorporationKCT2026-08-18
00724995240622V. MuellerSteris CorporationKCT2026-08-18
00724995240639V. MuellerSteris CorporationKCT2026-08-18
00724995240714V. MuellerSteris CorporationKCT2026-08-18
00724995240721V. MuellerSteris CorporationKCT2026-08-18
00724995240738V. MuellerSteris CorporationKCT2026-08-18
00724995240745V. MuellerSteris CorporationKCT2026-08-18
00724995240752V. MuellerSteris CorporationKCT2026-08-18
00724995240769V. MuellerSteris CorporationKCT2026-08-18
00724995240776V. MuellerSteris CorporationKCT2026-08-18
00724995240783V. MuellerSteris CorporationKCT2026-08-18
00724995240790V. MuellerSteris CorporationKCT2026-08-18
00724995240806V. MuellerSteris CorporationKCT2026-08-18
00724995240813V. MuellerSteris CorporationKCT2026-08-18
00724995240820V. MuellerSteris CorporationKCT2026-08-18
00724995240837V. MuellerSteris CorporationKCT2026-08-18
00724995240844V. MuellerSteris CorporationKCT2026-08-18
00724995240851V. MuellerSteris CorporationKCT2026-08-18
00724995240868V. MuellerSteris CorporationKCT2026-08-18
00724995240875V. MuellerSteris CorporationKCT2026-08-18
00724995240882V. MuellerSteris CorporationKCT2026-08-18
00724995240899V. MuellerSteris CorporationKCT2026-08-18