FDA.reportPublic FDA data

General Instrument

Primary DI
00841132125014
Brand
General Instrument
Company
ORTHOPEDIATRICS CORP.
Model
01-1003-3001
Catalog number
01-1003-3001
Device description
4.0mm Tap, Cannulated
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWXTAP, BONE
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132125014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132125014008411321250148411321250140841132125014

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840194499248Contracture ManagementNS-6000-4001NS-6000-40012026-03-02
00840194499255Contracture ManagementNS-6000-4101NS-6000-41012026-03-02
00840194499262Contracture ManagementNS-6000-4002NS-6000-40022026-03-02
00840194499279Contracture ManagementNS-6000-4102NS-6000-41022026-03-02
00840536823717VerteGlide Spinal Growth Guidance System03-1721-450303-1721-45032026-07-24
00840536823724VerteGlide Spinal Growth Guidance System03-1723-550303-1723-55032026-07-24
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800068983558BENCOXCorentec Co., LtdKIJ2026-07-24
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361350OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361367OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
18257200076581CETRAOrthofix US LLCHWX2026-07-17
18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
008401944957693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944957763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944958063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.KIJ2026-06-10
08809260475649TRAUS SSG40Saeshin Precision Co., Ltd.KIJ2026-05-19
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
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