FDA.reportPublic FDA data

MENIX

Primary DI
03760304680557
Brand
MENIX
Company
S.B.M
Model
MENIX Suture cutter
Catalog number
MEN9000398
Device description
MENIX Suture cutter to be used with MENIX and MENIX DUO devices in meniscal repair.
Published
2023-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXZCutter, Wire
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760304680557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760304680557037603046805573760304680557

GMDN Terms#

Term, Definition table
TermDefinition
Suture cutter, reusableA dedicated hand-held surgical instrument designed for cutting sutures. It will typically have a protected scalpel-like blade which may be fixed or have a scissors-like cutting action. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
772462123
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760154001083OTISImpactor bodyEVO90694442023-12-19
03760154001090OTISImpactor tipEVO90694462023-12-19
03760304681738LIGAFIX / PULLUPPin Set PULLIG90032025-12-11
03760304681745LIGAFIXPin Set LIG90000042025-12-11
03760304681752LIGAFIXPin Set LIG90000052025-12-11
03760304681776PULLUPPin Set PULLUP90082025-12-11
03760304681592PULLUPReusable suture retriever pin x5PUL90053032025-12-10
03760304681608PULLUPReusable suture retriever pin x10PUL90103032025-12-10
03760304681615ecoPass LSuture passer automatic grasper Large (Shoulder)EPA90004542025-06-26
03760304681622ecoPass SSuture passer automatic grasper - KneeMEN90004552025-06-26
03760304681639ecoPassNon sterile needle (x1)ANS90014612025-06-26
03760304681646ecoPassNon sterile needle (x5)ANS90054612025-06-26
03760304681653ecoPassNon sterile needle (x10)ANS90104612025-06-26
03760304681769BTLOOPPin Set PULLIG90072025-11-20
03760154006224OTIS-C-PLUSDrill bitEVO90351002023-12-21
03760154006248OTIS-C-PLUSCountersink bitEVO90402032023-12-21
03760304680045RetroTechDrill bitLIG90002942023-12-21
03760154003704PULLUPReusable suture retriever pin x1PUL90003032023-12-20
03760154005791LIGAFIXDrill bitLIG9009289 2023-12-20
03760154005814LIGAFIXRouter bitLIG90100722023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810207784005Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784012Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784029Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00190776421694MillenniumAvalign Technologies, Inc.NBH2026-06-24
00198506091551ELMED INCORPORATEDELMED INCORPORATEDNBH2026-06-10
00198506091575ELMED INCORPORATEDELMED INCORPORATEDNBH2026-06-10
00857915007804STRATOS Endoscopic Release System (GEN 2) Case of 5A.M. SURGICAL, INC.NBH2026-06-10
10845854087558Infinity™Conmed CorporationNBH2026-06-10
20857915007815STRATOS Endo Release Kit (GEN 2) Case of 5A.M. SURGICAL, INC.NBH2026-06-10
00857915007705STRATOS (Gen2)A.M. SURGICAL, INC.NBH2026-06-05
00857915007033RetraBE Single - Gen 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)A.M. SURGICAL, INC.NBH2026-06-04
00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
00857915007699Locking AttachmentA.M. SURGICAL, INC.NBH2026-05-20
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
07630345721204Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721211Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721228Surgical Manual InstrumentMedacta International SANBH2026-03-30
10080196385386MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385478MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392032MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392070MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392292MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385218MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-01-29
10080196387984MedlineMEDLINE INDUSTRIES, INC.NBH2023-10-09
B382SD48820700Surgical DirectSurgical Direct, Inc.NBH2023-05-24
07630345778765Sports Med InstrumentsMedacta International SANBH2023-01-16