FDA.report

HNM MEDICAL

Primary DI
00812171024095
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-17-0304-040
Catalog number
HNM-17-0304-040
Device description
BONE TUNNEL REAMER, 4MM
Published
2023-04-01
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

Related Records

Product Codes

CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812171024095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812171024095008121710240958121710240950812171024095

GMDN Terms

TermDefinition
Orthopaedic bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods

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

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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
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