FDA.reportPublic FDA data

UroDapter®/MID-II

Primary DI
05996617000050
Brand
UroDapter®/MID-II
Company
PHARMICO MEDICAL Korlátolt Felelősségű Társaság
Model
17001
Device description
Urological syringe adapter replacing the traditional catheter for pain-free bladder instillation, enables the treatment of the bladder and the urethra at the same time, which is impossible with a catheter.
Published
2025-08-25
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
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05996617000326PackageGS1100In Commercial Distribution
05996617000333PackageGS1100In Commercial Distribution
05996617000814PackageGS15In Commercial Distribution
05996617000821PackageGS110In Commercial Distribution
05996617000876PackageGS120In Commercial Distribution
05996617000050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05996617000326059966170003265996617000326
05996617000333059966170003335996617000333
05996617000814059966170008145996617000814
05996617000821059966170008215996617000821
05996617000876059966170008765996617000876
05996617000050059966170000505996617000050

GMDN Terms#

Term, Definition table
TermDefinition
Urethral intravesical infusion tipA small luminal device intended to be fitted onto a syringe (not included) to allow for administration of fluids (e.g., pharmaceuticals) into the bladder (intravesical) via the urethra. It includes a short tip intended to be inserted into the urethra with a flange intended to prevent leakage/backflow during instillation. It is intended for use on both male and female patients as an alternative to urethral instillation via a catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length32Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+36209451561jeno.kunovits@urosystem.com

Regulatory Flags#

DUNS number
860789069
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
00190776408459MillenniumAvalign Technologies, Inc.KOA2025-08-11
00190776408121MillenniumAvalign Technologies, Inc.KOA2025-08-06
00198506084416ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084430ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084447ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084454ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05