FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962145227
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-61-0367
Catalog number
HNM-1-61-0367
Device description
" HOUSE STRUT CALIPER, 6 1/2"", MARKER 3.5MM FROM TIP"
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
KTZCaliper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962145227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962145227008429621452278429621452270842962145227

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). 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
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03662663244701Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
03662663244800Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
00887868457180Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
00888480500834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663131957Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663194020PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663194037PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663126137Vital Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-07
00763000684112N/AMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-09-08
00194613115111MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-08-01
00190376585628InvictusALPHATEC SPINE, INC.KTZ2025-05-01
04719886908275USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KTZ2025-04-30
00194613050023MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00194613081515MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00763000864675n/aMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-03-11
09421028119290Kinematic Alignment Caliper – S+NENZTEC LIMITEDKTZ2025-01-24
00840343724863GEN2SURGIX MEDICAL LLCKTZ2025-01-13
00841336107144Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336107151Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336107236Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336108868Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109674Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109681Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109933Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109964Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11