FDA.reportPublic FDA data

Anmuth Medical International

Primary DI
08403207009746
Brand
Anmuth Medical International
Company
Anmuth Medical International, LLC
Model
38-664-16
Catalog number
38-664-16
Device description
"Phenolic Handle Long Osteotome, 15mm Wide, 15"""
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08403207009746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08403207009746084032070097468403207009746

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(413)478-9876marc@anmuthmedical.com

Regulatory Flags#

DUNS number
786500830
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
08403207010032Anmuth Medical International39-539-0339-539-032025-06-09
08403207009500Anmuth Medical International39-110-0039-110-002025-06-09
08403207009517Anmuth Medical International39-112-0039-112-002025-06-09
08403207009524Anmuth Medical International39-138-0039-138-002025-06-09
08403207009579Anmuth Medical International39-172-0039-172-002025-06-09
08403207009647Anmuth Medical International39-311-2039-311-202025-06-09
08403207009807Anmuth Medical International39-525-0639-525-062025-06-09
08403207010162Anmuth Medical International39-546-54TC39-546-54TC2025-06-09
08403207010179Anmuth Medical International39-547-24TC39-547-24TC2025-06-09
08403207010261Anmuth Medical International39-557-2539-557-252025-06-09
08403207010278Anmuth Medical International39-559-40TC39-559-40TC2025-06-09
08403207010285Anmuth Medical International39-559-47TC39-559-47TC2025-06-09
08403207010292Anmuth Medical International39-560-57TC39-560-57TC2025-06-09
08403207010346Anmuth Medical International39-630-0039-630-002025-06-09
08403207010353Anmuth Medical International39-633-2039-633-202025-06-09
08403207010360Anmuth Medical International39-635-1739-635-172025-06-09
08403207010377Anmuth Medical International39-650-2339-650-232025-06-09
08403207010384Anmuth Medical International39-666-0639-666-062025-06-09
08403207009531Anmuth Medical International39-160-0039-160-002025-06-05
08403207009548Anmuth Medical International39-161-1339-161-132025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10603295080770NADEPUY (IRELAND)HWM2018-09-24
10603295080787NADEPUY (IRELAND)HWM2018-09-24
10603295080794NADEPUY (IRELAND)HWM2018-09-24
10603295083160SIGMADEPUY (IRELAND)HWM2018-09-24
10603295083191SIGMADEPUY (IRELAND)HWM2018-09-24
10603295090403GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090410GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090427GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090434GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090441GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090458GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295122739NADEPUY (IRELAND)HWM2018-09-24
10603295122746NADEPUY (IRELAND)HWM2018-09-24
10603295122753NADEPUY (IRELAND)HWM2018-09-24
10603295122760NADEPUY (IRELAND)HWM2018-09-24
10603295122777NADEPUY (IRELAND)HWM2018-09-24
10603295122784NADEPUY (IRELAND)HWM2018-09-24
10603295122791NADEPUY (IRELAND)HWM2018-09-24
10603295123071MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123088MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123095MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123101MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24