FDA.reportPublic FDA data

TruCath

Primary DI
00850045818357
Brand
TruCath
Company
HR PHARMACEUTICALS INC.
Model
RR16
Device description
"TruCath® Red Rubber Intermittent Urethral Catheter, 16 Fr 16"" Length"
Published
2025-01-24
Public version status
New
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
EYBCATHETER, URETERAL, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850045818354PackageGS1100In Commercial Distribution
50850045818352PackageGS13In Commercial Distribution
00850045818357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004581835410850045818354
5085004581835250850045818352
00850045818357008500458183578500458183570850045818357

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110sbenser@hrhealthcare.com

Regulatory Flags#

DUNS number
828918164
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851809002425Surgilube2810205022810205022018-08-27
00851809002449Surgilube2810205362810205362018-08-27
00851809002852EcoVue2852852018-07-16
00850025153027Vitus5205202021-05-19
00850025153034Vitus5215212021-05-19
00850025153041Vitus5225222021-05-19
00850025153089Vitus5135132023-03-31
00850058254333TruLockTLFC12025-03-03
00850058254364TruLockTLFC52025-03-03
00850058254371TruLockTLFCP2025-03-03
00850067913009TruLockTLFS302026-03-06
00850067913016TruLockTLFS562026-03-06
00850058254579LivLIV082026-03-30
00850058254586LivLIV102026-03-30
00850058254593LivLIV122026-03-30
00850058254609LivLiv142026-03-30
00850025153188MTG32108321082022-09-28
00850025153195MTG32110321102022-09-28
00850025153218MTG32112321122022-09-28
00850025153232MTG32114321142022-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03600040963869ColoplastColoplast A/SEYB2026-01-30
03600040963920ColoplastColoplast A/SEYB2026-01-30
03600040964019ColoplastColoplast A/SEYB2026-01-30
03600040964071ColoplastColoplast A/SEYB2026-01-30
03600040964163ColoplastColoplast A/SEYB2026-01-30
03600040964224ColoplastColoplast A/SEYB2026-01-30
03600040964286ColoplastColoplast A/SEYB2026-01-30
03600040964347ColoplastColoplast A/SEYB2026-01-30
03600040964408ColoplastColoplast A/SEYB2026-01-30
03600040964644ColoplastColoplast A/SEYB2026-01-30
03600040965870ColoplastColoplast A/SEYB2026-01-30
03600040965931ColoplastColoplast A/SEYB2026-01-30
03600040965993ColoplastColoplast A/SEYB2026-01-30
03600040966051ColoplastColoplast A/SEYB2026-01-30
03600040966112ColoplastColoplast A/SEYB2026-01-30
03600040966204ColoplastColoplast A/SEYB2026-01-30
03600040966297ColoplastColoplast A/SEYB2026-01-30
03600040966389ColoplastColoplast A/SEYB2026-01-30
03600040966471ColoplastColoplast A/SEYB2026-01-30
03600040966532ColoplastColoplast A/SEYB2026-01-30
03600040966594ColoplastColoplast A/SEYB2026-01-30
03600040966655ColoplastColoplast A/SEYB2026-01-30
03600040966716ColoplastColoplast A/SEYB2026-01-30
03600040966778ColoplastColoplast A/SEYB2026-01-30
03600040966839ColoplastColoplast A/SEYB2026-01-30
03600040966891ColoplastColoplast A/SEYB2026-01-30
03600040966983ColoplastColoplast A/SEYB2026-01-30
03600040967041ColoplastColoplast A/SEYB2026-01-30
03600040967133ColoplastColoplast A/SEYB2026-01-30
03600040967195ColoplastColoplast A/SEYB2026-01-30