FDA.report

ELMED

Primary DI
00842180163799
Brand
ELMED
Company
ELMED INCORPORATED
Model
31-40-18
Catalog number
31-40-18
Device description
VAN BUREN SOUND 18 FR
Published
2023-04-21
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

Related Records

Contact Domains

Product Codes

CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180163799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180163799008421801637998421801637990842180163799

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

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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
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25
00190776408459MillenniumAvalign Technologies, Inc.KOA2025-08-11
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00198506084416ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
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00190776405076MillenniumAvalign Technologies, Inc.KOA2025-07-11
00198506083969ELMED INCORPORATEDELMED INCORPORATEDKOA2025-07-11
00198506084003ELMED INCORPORATEDELMED INCORPORATEDKOA2025-07-11
00198506084010ELMED INCORPORATEDELMED INCORPORATEDKOA2025-07-11
00190776404536MillenniumAvalign Technologies, Inc.KOA2025-07-09
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00190776404369MillenniumAvalign Technologies, Inc.KOA2025-07-07