FDA.reportPublic FDA data

TraumaOne SYSTEM

Primary DI
00888233009294
Brand
TraumaOne SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
46-0012
Catalog number
46-0012
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTETROCAR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233009294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233009294008882330092948882330092940888233009294

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
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
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445930615SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930622SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930639SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930646SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930653SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930660SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
04046826472153MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKTE2025-12-17
04250381812860Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-10-05
04250381812846Antrum trocar, beakedSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812853Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812877Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
00757770422029Bausch + LombBausch & Lomb IncorporatedKTE2024-11-21
00887482053300Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KTE2024-08-15
10381780540120MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
10381780538530MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
00381780105872MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
14026704912053PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
24026704912050PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
00888515242265BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515242272BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243262BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243279BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
G586E1063390Novo SurgicalNOVO SURGICAL, INC.KTE2023-12-18
07899893232154NEONAILNeoortho Produtos Ortopédicos S/A.KTE2023-11-29
00190776378455MillenniumAvalign Technologies, Inc.KTE2023-11-13
00190776322687MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
00190776375201MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
14026704809278PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
54026704809276PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
00842331163500Novo Surgical Inc. NOVO SURGICAL, INC.KTE2022-11-13