FDA.reportPublic FDA data

OTIS-C-PLUS

Primary DI
03760154006248
Brand
OTIS-C-PLUS
Company
S.B.M
Model
Countersink bit
Catalog number
EVO9040203
Device description
OTIS-C-PLUS® countersink bit
Published
2023-12-21
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760154006248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760154006248037601540062483760154006248

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. 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
03760304680045RetroTechDrill bitLIG90002942023-12-21
03760154003704PULLUPReusable suture retriever pin x1PUL90003032023-12-20
03760154005791LIGAFIXDrill bitLIG9009289 2023-12-20
03760154005814LIGAFIXRouter bitLIG90100722023-12-20
03760154005845LIGAFIXRouter bitLIG90105722023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017515A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017560A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017577A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017584A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00810030811657InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
00810030811671InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
04052536161836neon3Ulrich GmbH & Co. KGHTW2026-05-28
04052536161867neon3Ulrich GmbH & Co. KGHTW2026-05-28
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05