FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515237124
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
93-0131
Catalog number
93-0131
Device description
Converse Guard Chisel, 6mm wd, cvd left 7 1/2"
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515237124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515237124008885152371248885152371240888515237124

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
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
00888515149311BOSS Instruments90-7060P90-7060P2024-12-11
00888515231184BOSS Instruments90-700590-70052024-12-11
00888515231191BOSS Instruments90-700790-70072024-12-11
00888515231207BOSS Instruments90-700990-70092024-12-11
00888515231214BOSS Instruments90-701190-70112024-12-11
00888515231221BOSS Instruments90-701390-70132024-12-11
00888515231238BOSS Instruments90-702090-70202024-12-11
00888515231245BOSS Instruments90-702290-70222024-12-11
00888515231252BOSS Instruments90-702490-70242024-12-11
00888515231269BOSS Instruments90-702690-70262024-12-11
00888515231276BOSS Instruments90-702890-70282024-12-11
00888515231283BOSS Instruments90-703990-70392024-12-11
00888515231290BOSS Instruments90-7039P90-7039P2024-12-11
00888515231306BOSS Instruments90-704090-70402024-12-11
00888515231320BOSS Instruments90-7040P90-7040P2024-12-11
00888515231337BOSS Instruments90-704290-70422024-12-11
00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
00888515231399BOSS Instruments90-704690-70462024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536017546tezoUlrich GmbH & Co. KGFZO2026-03-12
00190776417598MillenniumAvalign Technologies, Inc.FZO2026-03-04
00190776417604MillenniumAvalign Technologies, Inc.FZO2026-03-04
03662663109215Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
03662663109222Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
04058749067538NAFehling Instruments GmbH & Co. KGFZO2026-01-28
04058749075991NAFehling Instruments GmbH & Co. KGFZO2026-01-28
00190776415280MillenniumAvalign Technologies, Inc.FZO2026-01-27
00889024703872Offset Box OsteotomeZimmer, Inc.FZO2025-12-18
03662663271349Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271356Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271363Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271370Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271394Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271400Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271417Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271431Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271455Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271462Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271479Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271493Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271509Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271516Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271523Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271530Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271547Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271554Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271561Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271578Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271585Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18