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
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089526579AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528047AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528344AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528351AMPLITUDEAMPLITUDE SASHTW2026-07-29