FDA.reportPublic FDA data

SutureOut

Primary DI
00714646001184
Brand
SutureOut
Company
Bionix, LLC
Model
28500
Catalog number
28500
Device description
SutureOut, 3ct Sample
Published
2024-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCUTTER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646001184PrimaryGS10
10714646001181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646001184007146460011847146460011840714646001184
1071464600118110714646001181

GMDN Terms#

Term, Definition table
TermDefinition
Suture cutter, single-useA hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
3
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911004184Bionix Development Corporation370037002017-01-28
00859911004498Safe Ear Curette™ Variety Kit577757772021-12-10
00859911004429Green MicroLoop®122212222021-12-10
00859911004436Orange ControLoop®299929992021-12-10
00859911004443Red AngleLoop®344434442021-12-10
00859911004450Purple VersaLoop®411141112021-12-10
00859911004467Blue InfantScoop®488848882021-12-10
00859911004474Yellow CeraSpoon®633363332021-12-10
00859911004481White FlexLoop®955595552021-12-10
00859911004528Lighted AngleLoop®221022102021-12-10
00859911004535Lighted MicroLoop®222022202021-12-10
00859911004542Lighted WaveCurette™223022302021-12-10
00859911004559Lighted FlexLoop®224022402021-12-10
00859911004566Lighted Ear Curette™ Variety Pack224522452021-12-10
00859911004573Lighted CeraSpoon®225022502021-12-10
00859911004580Lighted InfantScoop®226022602021-12-10
00859911004597Lighted VersaLoop®227022702021-12-10
00859911004603Lighted CeraPik™228022802021-12-10
00859911004702Lighted Forceps for Foreign Body Removal275027502021-12-10
00859911004726Lighted Placement Tool285028502022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200131303Firebird SI FusionOrthofix US LLCFZT2026-07-17
00841435119062TecometTECOMET INC.FZT2026-06-08
G149TBSB7890TBS BASICSACME ENTERPRISE.FZT2026-05-21
14250368861550KURZ Precise Cartilage Knife SetHeinz Kurz GmbHFZT2026-05-21
08717903490594Humeca MAX MesherHumeca B.V.FZT2026-03-31
00810207782209Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDFZT2025-11-24
00192896122499Cartilage Graft CutterSONTEC INSTRUMENTS, INC.FZT2025-11-21
03662663113151Virage OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-11-12
04049197556552RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZT2025-10-15
10649111400117Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400124Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400131Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
E896294920SCHWERTA. Schweickhardt GmbH & Co. KGFZT2025-05-22
10649111078910Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111079092Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488115Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488122Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
00850037506262MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-09-18
00850037506231MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506248MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506255MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00714646000781SutureOutBionix, LLCFZT2024-04-23
10197106247327CARDINAL HEALTHCardinal Health 200, LLCFZT2023-09-14
00818069010997TecometTECOMET INC.FZT2023-08-10
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
05010058070950InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
05010058070974InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
05010058071599InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
00818069014902TecometTECOMET INC.FZT2023-07-21
00841435120105TecometTECOMET INC.FZT2023-07-21