FDA.reportPublic FDA data

NeuroPro®

Primary DI
00898142001203
Brand
NeuroPro®
Company
Kinamed, Inc.
Model
14-1S1-1605
Catalog number
14-1S1-1605
Device description
Bone Screw, 1.6 x 5mm
Published
2015-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898142001203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898142001203008981420012038981420012030898142001203

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate screwA small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184896645
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818720011608SuperCable® Grip and Plate System35-860-206535-860-20652023-06-21
00818720011547SuperCable® Grip and Plate System35-860-102035-860-10202023-06-20
00818720011578SuperCable® Grip and Plate System35-860-202035-860-20202023-06-20
00818720011585SuperCable® Grip and Plate System35-860-203035-860-20302023-06-20
00898142001357SuperCable® Iso-Elastic™ Cerclage System35-100-101035-100-10102015-11-04
00898142001975SuperCable® Iso-Elastic™ Cerclage System37-100-101037-100-10102015-11-04
00818720012438CarboJet XF® Bone Preparation System27-100-114027-100-11402023-07-10
00818720010007SuperCable® Grip and Plate System35-200-101035-200-10102015-10-28
00818720010014SuperCable® Grip and Plate System35-200-102035-200-10202015-10-28
00818720010021SuperCable® Grip and Plate System35-200-103035-200-10302015-10-28
00818720010038SuperCable® Grip and Plate System35-200-104035-200-10402015-10-27
00818720010069SuperCable® Grip and Plate System35-220-101035-220-10102015-10-28
00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
00818720010083SuperCable® Grip and Plate System35-220-201235-220-20122015-10-28
00818720010090SuperCable® Grip and Plate System35-220-301035-220-30102015-10-28
00818720010106SuperCable® Grip and Plate System35-220-301235-220-30122015-10-28
00818720010113SuperCable® Grip and Plate System35-230-451035-230-45102015-10-30
00818720010120SuperCable® Grip and Plate System35-230-451235-230-45122015-10-30
00818720010137SuperCable® Grip and Plate System35-230-451435-230-45142015-10-30
00818720010144SuperCable® Grip and Plate System35-230-451635-230-45162015-10-30

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