FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962140673
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-57-6305
Catalog number
HNM-1-57-6305
Device description
MICHELE TREPHINE, 6 1/4", SHAFT GRADUATED, 5MM
Published
2023-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWKTrephine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962140673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962140673008429621406738429621406730842962140673

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus trephineAn ear/nose/throat (ENT) surgical blade designed to cut and remove circular sections of bone or mucous membrane from the paranasal sinuses. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
806754185
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
false
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
10841742143672HNM MEDICALHNM-1-09-8310SHNM-1-09-8310S2025-05-16
10841742149476HNM MEDICALHNM-1-09-8308SHNM-1-09-8308S2025-05-16
10841742149483HNM MEDICALHNM-1-09-8312SHNM-1-09-8312S2025-05-16
00841742149585HNM MedicalHNM-1-57-2097HNM-1-57-20972025-04-18
00841742149592HNM MedicalHNM-1-57-2099HNM-1-57-20992025-04-18
00841742149608HNM MedicalHNM-1-57-2098HNM-1-57-20982025-04-18
10841742149353HNM MedicalHNM-45-002HNM-45-0022025-01-27
10841742149377HNM MEDICALHNM-1-62-2210SHNM-1-62-2210S2025-01-27
10841742149384HNM MEDICALHNM-1-62-2215SHNM-1-62-2215S2025-01-27
10841742149391HNM MEDICALHNM-1-62-2220SHNM-1-62-2220S2025-01-27
00841742149233HNM MedicalHNM-1-550-1524HNM-1-550-15242024-11-18
00841742148939HNM MedicalHNM-250-000-011HNM-250-000-0112024-11-08
00841742148946HNM MedicalHNM-250-000-012HNM-250-000-0122024-11-08
00841742148953HNM MedicalHNM-250-000-013HNM-250-000-0132024-11-08
00841742149219HNM MedicalHNM-250-000-014HNM-250-000-0142024-11-08
10841742149124HNM MEDICALHBI-BA-100HBI-BA-1002024-08-30
10841742148929HNM MEDICALHNM-17506HNM-175062024-05-14
00841742148854HNM MedicalHNM-250-000-001HNM-250-000-0012024-04-01
00841742148861HNM MedicalHNM-250-000-002HNM-250-000-0022024-04-01
00841742148878HNM MedicalHNM-250-000-003HNM-250-000-0032024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663217477Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217484Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217491Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217507Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663134392C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHWK2025-12-03
03662663136327Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136334Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136341Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136358Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136365Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
10193489179583MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
10193489179590MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
00850055649705INTREPED Extraction KitAuxano Medical LLCHWK2025-01-10
00190776384609MillenniumAvalign Technologies, Inc.HWK2024-08-22
00190776384616MillenniumAvalign Technologies, Inc.HWK2024-08-22
B756STR00107SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00108SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00109SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00110SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00111SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00112SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00113SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00114SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00115SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00116SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00117SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00118SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00119SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00120SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00121SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21