FDA.reportPublic FDA data

Two-Piece Slotted Cannula Kit

Primary DI
90841823100071
Brand
Two-Piece Slotted Cannula Kit
Company
AD-TECH MEDICAL INSTRUMENT CORPORATION
Model
2SCK1-240X
Catalog number
2SCK1-240X
Published
2021-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90841823100071PackageGS12In Commercial Distribution
00841823100078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
9084182310007190841823100071
00841823100078008418231000788418231000780841823100078

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags#

DUNS number
174813410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841823111029Depth ElectrodeMM16H-SP05X-0D5MM16H-SP05X-0D52026-06-03
00841823108814Anchor Bolt Kit, LSB StyleLSBK1-AX-05LSBK1-AX-052026-04-08
00841823108821Anchor Bolt Kit, LSB StyleLSBK1-BX-05LSBK1-BX-052023-08-28
00841823108838Anchor Bolt Kit, LSB StyleLSBK1-CX-04LSBK1-CX-042023-08-28
00841823108845Anchor Bolt Kit, LSB StyleLSBK1-CX-05LSBK1-CX-052023-08-28
00841823108852Anchor Bolt Kit, LSB StyleLSBK2-AX-04LSBK2-AX-042023-08-28
00841823108869Anchor Bolt Kit, LSB StyleLSBK2-BX-04LSBK2-BX-042023-08-28
00841823109521Anchor Bolt Kit, LSB StyleLSBK1-CX-06LSBK1-CX-062023-08-28
00841823109538Anchor Bolt Kit, LSB StyleLSBK1-BX-06LSBK1-BX-062023-08-28
00841823109545Anchor Bolt Kit, LSB StyleLSBK1-AX-06LSBK1-AX-062023-08-28
00841823101228Subdural ElectrodeDG20A-SP07X-UPBDG20A-SP07X-UPB2016-09-23
00841823101235Subdural ElectrodeDG20A-SP10X-G00DG20A-SP10X-G002016-09-23
00841823101242Subdural ElectrodeDG20A-SP10X-GE2DG20A-SP10X-GE22016-09-23
00841823101259Subdural ElectrodeDG20A-SP10X-T00DG20A-SP10X-T002016-09-23
00841823101266Subdural ElectrodeDG20A-SP10X-U00DG20A-SP10X-U002016-09-23
00841823101273Subdural ElectrodeDG20A-SP10X-UE2DG20A-SP10X-UE22016-09-23
00841823101280Subdural ElectrodeDG24A-SP10X-000DG24A-SP10X-0002016-09-23
00841823101297Subdural ElectrodeDG24A-SP10X-G00DG24A-SP10X-G002016-09-23
00841823101303Subdural ElectrodeDG32A-SP10X-U00DG32A-SP10X-U002016-09-23
00841823101310Subdural ElectrodeDG32A-SP10X-V00DG32A-SP10X-V002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456482Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456505Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456413Medco ManufacturingMedco Manufacturing LLCGEA2026-06-02
00846338005436Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007324Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007331Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007348Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007355Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007362Working PortELLIQUENCE, LLCGEA2026-06-02
00846338005535Suction TubeELLIQUENCE, LLCGEA2026-06-01
00846338005542Suction TubeELLIQUENCE, LLCGEA2026-06-01
00810130456390Medco ManufacturingMedco Manufacturing LLCGEA2026-05-29
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13