FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515223608
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
85-0150
Catalog number
85-0150
Device description
"Obwegeser Zygomatic Arch Awl, cvd, 9"""
Published
2024-02-28
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
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515223608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515223608008885152236088885152236080888515223608

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. 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
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
04048844406547n/aimplantcast GmbHHWJ2026-04-07
04052536216161uCentumUlrich GmbH & Co. KGHWJ2026-03-31
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
04047844128190CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
04047844128206CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
00841732134393GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134409GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134416GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134423GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732135406GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139411GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139428GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732163850GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
00841732163935GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
008100747560374WEB Medical4web MedicalHWJ2023-02-13