FDA.reportPublic FDA data

12mm Dilator

Primary DI
00810097800366
Brand
12mm Dilator
Company
Osteocentric Technologies, Inc.
Model
1252-4110
Catalog number
1252-4110
Device description
12mm Dilator
Published
2022-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZWExpander, Surgical, Skin Graft
FZXGuide, Surgical, Instrument
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810097800366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097800366008100978003668100978003660810097800366

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic dilation guide rodA compact metal rod intended to be used during expansion of a laparoscopic access port (e.g., from 10 to 20 mm) by facilitating: 1) removal of an existing access cannula; and 2) introduction of a dilator/cannula assembly. It is inserted into the existing access cannula, keeping the opening airtight whilst the smaller access cannula is removed; a special dilator assembled with a larger access cannula is fed back over the guide rod. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
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
008100978037493.0mm GUIDE WIRE 355mm202-80600202-806002026-06-02
00810118210198Torque Wrench701-0019701-00192023-10-31
00810118210259.050 Driver, Short701-0025701-00252023-10-31
00810118210266.050 Driver, Long701-0026701-00262023-10-31
00810118210273.050 Driver, Latch701-0027701-00272023-10-31
00810118210280Thumb Knob701-0029701-00292023-10-31
00810118210327Latch Driver, 300 Series701-0033701-00332023-10-31
00810118210334Square Driver, 300 Series701-0034701-00342023-10-31
00810118210341Latch Driver, 400 Series701-0035701-00352023-10-31
00810118210358Square Driver, 400 Series701-0036701-00362023-10-31
00810118210365Ratchet Adapter701-0037701-00372023-10-31
008101182100063.7mm Tap701-0013701-00132023-10-30
008101182100134.2mm Tap701-0014701-00142023-10-30
008101182100205.5mm Tap701-0015701-00152023-10-30
00810118210129Drill Extender701-0009701-00092023-10-30
008101182101673.7mm Parallel Pin701-0016701-00162023-10-30
008101182101744.2mm Parallel Pin701-0017701-00172023-10-30
008101182101815.5mm Parallel Pin701-0018701-00182023-10-30
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
10855068008577Steerable Guide Sleeve, Small ImplantCURVAFIX, INC.FZX2022-12-05
10855068008447Soft Tissue SleeveCURVAFIX, INC.FZX2022-06-20
10855068008454Drill SleeveCURVAFIX, INC.FZX2022-06-20
10855068008461Spiked Start Sleeve, CannulatedCURVAFIX, INC.FZX2022-06-20
10855068008478Steerable Guide SleeveCURVAFIX, INC.FZX2022-06-20
10886982066763NASYNTHES (U.S.A.) LPFZX2016-12-31
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