FDA.reportPublic FDA data

MTG

Primary DI
50850025153503
Brand
MTG
Company
HR PHARMACEUTICALS INC.
Model
12112
Catalog number
12112
Device description
Jiffy Mini-Pak 12 FR
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
50850025153503PackageGS1100In Commercial Distribution
00850025153508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085002515350350850025153503
00850025153508008500251535088500251535080850025153508

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828918164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253029079DoverCardinal Health 200, LLCKOD2025-04-07
10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
10192253029093DoverCardinal Health 200, LLCKOD2025-04-07
10192253029109DoverCardinal Health 200, LLCKOD2025-04-07
10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
10192253029123DoverCardinal Health 200, LLCKOD2025-04-07
10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
10192253030341DoverCardinal Health 200, LLCKOD2025-04-07
10192253030358DoverCardinal Health 200, LLCKOD2025-04-07
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253030648DoverCardinal Health 200, LLCKOD2025-01-15
10192253031041DoverCardinal Health 200, LLCKOD2025-01-15
10192253031423DoverCardinal Health 200, LLCKOD2025-01-15
10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253066203DoverCardinal Health 200, LLCKOD2024-09-04
10192253066210DoverCardinal Health 200, LLCKOD2024-09-04
10192253066227DoverCardinal Health 200, LLCKOD2024-09-04
10192253066234DoverCardinal Health 200, LLCKOD2024-09-04
10192253066241DoverCardinal Health 200, LLCKOD2024-09-04
10192253066258DoverCardinal Health 200, LLCKOD2024-09-04
10192253066265DoverCardinal Health 200, LLCKOD2024-09-04