FDA.reportPublic FDA data

UroLift® 2

Primary DI
00814932020018
Brand
UroLift® 2
Company
NEOTRACT, INC.
Model
UL500-H
Catalog number
UL500-H
Published
2016-11-15
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814932020015PackageGS12Not in Commercial Distribution
00814932020018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081493202001510814932020015
00814932020018008149320200188149320200180814932020018

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
877-408-9628customerservice@neotract.com

Regulatory Flags#

DUNS number
623519464
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814932020049UroLiftUL400-4UL400-42018-09-25
00814932020025UroLift® 2UL500-CUL500-C2016-11-15
10814932020022UroLift® 2UL500-CUL500-C2016-11-15
10814932020046UroLiftUL400-4UL400-42018-09-25
00814932020001UroLiftUL400-4UL400-42015-09-14
00814932020032UroLift® 2 UL500-HUL500-H2017-11-01
10814932020015UroLift® 2 UL500-HUL500-H2016-11-15
10814932020039UroLift® 2 UL500-HUL500-H2017-11-01

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
10814932020343UROLIFTTELEFLEX INCORPORATEDPEW2023-03-15
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