FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515236998
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
93-0116
Catalog number
93-0116
Device description
"Tardy Osteotome, 6 1/4"", 2mm wide edge"
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00888515236998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515236998008885152369988885152369980888515236998

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting 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 either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags#

DUNS number
848522678
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
00888515202146BOSS Instruments77-322077-32202024-02-28
00888515328037BOSS InstrumentsVSX233VSX2332025-10-28
00888515328044BOSS InstrumentsVSG511VSG5112025-10-28
00888515272026Stealth SurgicalSS3923SS39232016-10-01
00888515272040Stealth SurgicalSS3925SS39252016-10-01
00888515272064Stealth SurgicalSS3927SS39272016-10-01
00888515217515BOSS Instruments80-624080-62402024-02-28
00888515217522BOSS Instruments80-624280-62422024-02-28
00888515217539BOSS Instruments80-624480-62442024-02-28
00888515217546BOSS Instruments80-624680-62462024-02-28
00888515217553BOSS Instruments80-624880-62482024-02-28
00888515217560BOSS Instruments80-625080-62502024-02-28
00888515217577BOSS Instruments80-625280-62522024-02-28
00888515217584BOSS Instruments80-625380-62532024-02-28
00888515217591BOSS Instruments80-625480-62542024-02-28
00888515217638BOSS Instruments80-626080-62602024-02-28
00888515217645BOSS Instruments80-626180-62612024-02-28
00888515217683BOSS Instruments80-627080-62702024-02-28
00888515217690BOSS Instruments80-627580-62752024-02-28
00888515217706BOSS Instruments80-627880-62782024-02-28

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