FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704289435
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015518
Catalog number
KM64010
Device description
DITTEL URETHRAL SOUNDS 11 1/2" STRAIGHT 10 FRENCH
Published
2018-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704289431Direct MarkingGS10
24026704289435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704289431040267042894314026704289431
2402670428943524026704289435

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length29.2Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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Primary DI, Brand, Company table
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00190776394189MillenniumAvalign Technologies, Inc.FBX2025-05-07
00190776394196MillenniumAvalign Technologies, Inc.FBX2025-05-07
00840183530037BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530044BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530051BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530068BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530075BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530082BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530099BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530020BR Surgical, LLCBR Surgical, LLCFBX2025-04-15
00840183529789BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00840183529864BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00194613046507MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613100773MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
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00194613105006MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21