FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962125595
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-51-7210
Catalog number
HNM-1-51-7210
Device description
"OTIS BOUGIE A BOULE, 10"", 10FR"
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EYAStylet, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYAStylet, UreteralGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962125595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962125595008429621255958429621255950842962125595

GMDN Terms#

Term, Definition table
TermDefinition
Uterine sound, reusableA hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. 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 intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
806754185
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812171026570HNM MEDICALHKW-11-090009HKW-11-0900092019-05-30
00812171026587HNM MEDICALHKW-11-090011HKW-11-0900112019-05-30
00812171026594HNM MEDICALHKW-11-090016HKW-11-0900162019-05-30
00812171026600HNM MEDICALHKW-11-090014HKW-11-0900142019-05-30
00812171026617HNM MEDICALHKW-11-060014HKW-11-0600142019-05-30
00812171026624HNM MEDICALHKW-11-120009HKW-11-1200092019-05-30
00812171026631HNM MEDICALHKW-13-090016HKW-13-0900162019-05-30
00812171026679HNM MEDICALHKW-11-040011HKW-11-0400112019-05-30
00812171026686HNM MEDICALHKW-11-040016HKW-11-0400162019-05-30
00812171026693HNM MEDICALHKW-11-040014HKW-11-0400142019-05-30
00812171026709HNM MEDICALHKW-11-050007HKW-11-0500072019-05-30
00812171026716HNM MEDICALHKW-11-090020HKW-11-0900202019-05-30
00812171026723HNM MEDICALHKW-11-090024HKW-11-0900242019-05-30
00812171026730HNM MEDICALHKW-11-090028HKW-11-0900282019-05-30
00812171026747HNM MEDICALHKW-11-090032HKW-11-0900322019-05-30
00812171026754HNM MEDICALHKW-11-090035HKW-11-0900352019-05-30
00812171026761HNM MEDICALHKW-11-090040HKW-11-0900402019-05-30
00812171026778HNM MEDICALHKW-11-090045HKW-11-0900452019-05-30
00812171026785HNM MEDICALHKW-15-090020HKW-15-0900202019-05-30
00812171026792HNM MEDICALHKW-15-090024HKW-15-0900242019-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925003446GYRUS ACMI, INCGyrus ACMI, LLCEYA2024-07-24
G586UR96286210Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
G586UR96286410Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
00842962125588HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125601HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125618HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125625HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125632HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125649HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125656HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125670HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125687HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125694HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125700HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125717HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125724HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125731HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125748HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125755HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125762HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125809HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125816HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125823HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842331134531Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
00842331135897Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
00816349011733ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011740ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011757ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011764ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011788ZIPwire™Lake Region MedicalEYA2020-06-30