FDA.reportPublic FDA data

FOREFOOT II

Primary DI
10381780045458
Brand
FOREFOOT II
Company
NEWDEAL
Model
159227SND
Catalog number
159227S
Device description
AO "2 in 1" drill dia. 2.2/3.0mm L.12mm
Published
2018-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10381780045458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004545810381780045458

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M248119309ND1FOREFOOT SOLUTIONS™119309ND2017-05-26
M248119319ND1LARGE UNI-CLIP®119319ND2017-05-26
M248119321ND1LARGE UNI-CLIP®119321ND2017-05-26
M248239030ND1IPP-ON®239030ND2017-05-26
M248119510ND1I.CO.S®119510ND2017-05-26
M248119511ND1I.CO.S®119511ND2017-05-26
M248119532ND1I.CO.S®119532ND2017-05-26
M248119536ND1I.CO.S®119536ND2017-05-26
M248119562ND1I.CO.S®119562ND2017-05-26
M248119566ND1I.CO.S®119566ND2017-05-26
10381780045892IPP-ON230001SND230001SND2017-10-09
10381780045908IPP-ON230002SND230002SND2017-10-09
M248PANTAXLSET1PANTA XLPANTAXLSETPANTAXLSET2015-09-24
10381780125891PANTAREPANTASETREPANTASET2015-09-24
10381780064381B-BOPBBOPSETBBOPSET2017-10-09
M248119580ND1I.CO.S®119580ND2017-05-26
M248119590ND1I.CO.S®119590ND2017-05-26
M248139107ND1METIS®139107ND2017-05-26
M248529061ND1SURFIX®529061ND2017-06-06
10381780043317BASAL DORSAL PLATE116010SND116010SND2017-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190457NAPACIFIC INSTRUMENTS, INC.HTW2026-05-26
04048844358617MUTARS®implantcast GmbHHTW2026-03-24
04048844358716MUTARS®implantcast GmbHHTW2026-03-24
04048844358792MUTARS®implantcast GmbHHTW2026-03-24
04048844358839MUTARS®implantcast GmbHHTW2026-03-24
00840314270245gSourceGSOURCE LLCHTW2026-03-20
00840314270252gSourceGSOURCE LLCHTW2026-03-20
00840314270269gSourceGSOURCE LLCHTW2026-03-20
00763000884543n/aMEDTRONIC SOFAMOR DANEK, INC.HTW2026-03-13
00888867500891Arthrex®ARTHREX, INC.HTW2026-03-13
00888867500921Arthrex®ARTHREX, INC.HTW2026-03-13
00817438028618N/AOmega Surgical Instruments IncHTW2026-03-03
06974940307007endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307021endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307038endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
00889024706484Vanguard®Biomet Orthopedics, LLCHTW2026-02-27
00841435124929TecometTECOMET INC.HTW2026-02-26
08053782783731BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-02-19
00190376709253AMP IIALPHATEC SPINE, INC.HTW2026-02-18
00810112597455TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00810112598896TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00199150062973Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTW2026-02-09
00889024683891G7® Revision Acetabular SystemZimmer, Inc.HTW2026-02-05
04026575282883General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575299188TrabecuLink Augments InstrumentsWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575414932General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575427130General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
00810056993122corraCarlsmed, Inc.HTW2026-01-30
00810056993153corraCarlsmed, Inc.HTW2026-01-30
00810056993160corraCarlsmed, Inc.HTW2026-01-30