FDA.reportPublic FDA data

UROLIFT

Primary DI
10814932020343
Brand
UROLIFT
Company
TELEFLEX INCORPORATED
Model
IPN924184
Catalog number
UL2-C
Device description
UroLift 2 Implant Cartridge
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEWImplantable transprostatic tissue retractor system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEWImplantable Transprostatic Tissue Retractor SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201837000UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.2020-07-31PEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20814932020340PackageGS14In Commercial Distribution
10814932020343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081493202034020814932020340
1081493202034310814932020343

GMDN Terms#

Term, Definition table
TermDefinition
Prostatic retraction implantA sterile implantable device intended to increase prostatic urethral patency, and thereby relieve lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH), by physically compressing the prostate gland by retraction. The implant is in the form of a two orthogonal tags (e.g., metal) held together by a suture (e.g., monofilament), and is introduced so that one tag is outside the prostatic capsule and the other is in the urethra, with the suture providing retraction. It is not intended to be explanted. The device is implanted using a dedicated, single-use, hand-held, pistol-like delivery device through the sheath of a rigid endoscope.

Contacts#

Phone, Email table
PhoneEmail
+1(925)401-0700CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10814932020503UROLIFTTELEFLEX INCORPORATEDPEW2025-07-11
20814932020500UROLIFTTELEFLEX INCORPORATEDPEW2025-07-11
10814932020527UROLIFTTELEFLEX INCORPORATEDPEW2025-07-11
10814932020442UROLIFTTELEFLEX INCORPORATEDPEW2024-04-23
20814932020449UROLIFTTELEFLEX INCORPORATEDPEW2024-04-23
10814932021470UROLIFTTELEFLEX INCORPORATEDPEW2024-04-17
10814932020459UROLIFTTELEFLEX INCORPORATEDPEW2024-01-16
20814932020456UROLIFTTELEFLEX INCORPORATEDPEW2024-01-16
10814932020367UROLIFTTELEFLEX INCORPORATEDPEW2023-10-30
20814932020364UROLIFTTELEFLEX INCORPORATEDPEW2023-10-30
10814932020404UROLIFTTELEFLEX INCORPORATEDPEW2023-07-30
20814932020401UROLIFTTELEFLEX INCORPORATEDPEW2023-07-30
10814932020381UROLIFTTELEFLEX INCORPORATEDPEW2023-06-12
10814932020398UROLIFTTELEFLEX INCORPORATEDPEW2023-06-12
20814932020388UROLIFTTELEFLEX INCORPORATEDPEW2023-06-12
20814932020395UROLIFTTELEFLEX INCORPORATEDPEW2023-06-12
10814932020350UROLIFTTELEFLEX INCORPORATEDPEW2023-03-15
20814932020340UROLIFTTELEFLEX INCORPORATEDPEW2023-03-15
20814932020357UROLIFTTELEFLEX INCORPORATEDPEW2023-03-15
10814932020268UROLIFTTELEFLEX INCORPORATEDPEW2022-06-27
10814932020275UROLIFTTELEFLEX INCORPORATEDPEW2022-06-27
20814932020265UROLIFTTELEFLEX INCORPORATEDPEW2022-06-27
20814932020272UROLIFTTELEFLEX INCORPORATEDPEW2022-06-27
10814932020282UROLIFTTELEFLEX INCORPORATEDPEW2022-05-25
10814932020299UROLIFTTELEFLEX INCORPORATEDPEW2022-05-25
20814932020289UROLIFTTELEFLEX INCORPORATEDPEW2022-05-25
20814932020296UROLIFTTELEFLEX INCORPORATEDPEW2022-05-25
10814932020206UROLIFTTELEFLEX INCORPORATEDPEW2021-06-21
10814932020213UROLIFTTELEFLEX INCORPORATEDPEW2021-03-08
20814932020210UROLIFTTELEFLEX INCORPORATEDPEW2021-03-08