FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962124406
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-51-0507
Catalog number
HNM-1-51-0507
Device description
"BAKES DILATOR, 10"", MALLEABLE, 7MM WIDE "
Published
2023-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCCDilator, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962124406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962124406008429621244068429621244060842962124406

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

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
00850007350338Salivary Access Dilator SetC2DX, INC.GCC2026-02-10
00194613099848MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2025-08-01
00194613094942MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2024-08-15
00840183501945BR Surgical, LLCBR Surgical, LLCGCC2024-01-31
G586UR96282190Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282210Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282230Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282250Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282270Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282290Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282310Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
00840343718312GEN2SURGIX MEDICAL LLCGCC2023-09-05
00842331192661Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192678Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192685Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192692Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192708Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00840329829445Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GCC2023-05-10
00842962125571HNM MEDICALHNM STAINLESS, LLC.GCC2023-04-03
00842962125526HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125533HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125540HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125557HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125564HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962124345HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124352HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124369HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124376HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124383HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124390HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23