FDA.reportPublic FDA data

MTG

Primary DI
00850025153201
Brand
MTG
Company
HR PHARMACEUTICALS INC.
Model
32510
Catalog number
32510
Device description
EZ-Advancer 10FR
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080878000MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)Medical Technologies of Georgia, Inc.2008-07-17KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50850025153206PackageGS1100In Commercial Distribution
00850025153201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085002515320650850025153206
00850025153201008500251532018500251532010850025153201

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
828918164
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850067913238SteriGear®101362026-10-16
00850067913245SteriGear®101532026-10-16
00850067913252SteriGear®101542026-10-16
00850067913269SteriGear®102042026-10-16
00850067913276SteriGear®102242026-10-16
00850067913283SteriGear®102472026-10-16
00850067913054Fig Leaf®102732026-10-15
00850067913061Fig Leaf®102802026-10-15
00850067913078Fig Leaf®102862026-10-15
00850067913085SteriGear®101002026-10-15
00850067913092SteriGear®101012026-10-15
00850067913108SteriGear®101022026-10-15
00850067913115SteriGear®101072026-10-15
00850067913122SteriGear®101082026-10-15
00850067913139SteriGear®101092026-10-15
00850067913146SteriGear®101102026-10-15
00850067913153SteriGear®101112026-10-15
00850067913160SteriGear®101122026-10-15
00850067913177SteriGear®101192026-10-15
00850067913184SteriGear®101252026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741236563SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236570SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236587SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236600SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236617SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236624SURESTEPC. R. Bard, Inc.KOD2026-10-06
00801741236631SURESTEPC. R. Bard, Inc.KOD2026-10-06
14026704926944RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926951RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926968RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704933843RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253067651DoverCardinal Health 200, LLCKOD2025-04-14
10192253067668DoverCardinal Health 200, LLCKOD2025-04-14
10192253067675DoverCardinal Health 200, LLCKOD2025-04-14
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253066289DoverCardinal Health 200, LLCKOD2024-09-04
10192253066296DoverCardinal Health 200, LLCKOD2024-09-04
10192253066302DoverCardinal Health 200, LLCKOD2024-09-04
10192253066319DoverCardinal Health 200, LLCKOD2024-09-04