FDA.reportPublic FDA data

OPERACE

Primary DI
07610733850280
Brand
OPERACE
Company
PB SWISS TOOLS AG
Model
80028
Catalog number
80028
Device description
Sterile single use insert for the removal of screws with seperated screw head or broken screws
Published
2024-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07610733850280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07610733850280076107338502807610733850280

GMDN Terms#

Term, Definition table
TermDefinition
Screw-extraction orthopaedic reamer, single-useA surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41344377171info@pbswisstools.com

Regulatory Flags#

DUNS number
487856262
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07610733850013OPERACE80001800012024-09-24
07610733850020OPERACE80002800022024-09-24
07610733850037OPERACE80003800032024-09-24
07610733850044OPERACE80004800042024-09-24
07610733850051OPERACE80005800052024-09-24
07610733850068OPERACE80006800062024-09-24
07610733850075OPERACE80007800072024-09-24
07610733850082OPERACE80008800082024-09-24
07610733850099OPERACE80009800092024-09-24
07610733850105OPERACE80010800102024-09-24
07610733850112OPERACE80011800112024-09-24
07610733850150OPERACE80015800152024-09-24
07610733850181OPERACE80018800182024-09-24
07610733850198OPERACE80019800192024-09-24
07610733850204OPERACE80020800202024-09-24
07610733850211OPERACE80021800212024-09-24
07610733850228OPERACE80022800222024-09-24
07610733850235OPERACE80023800232024-09-24
07610733850242OPERACE80024800242024-09-24
07610733850259OPERACE80025800252024-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592337TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592344TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592351TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592368TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592375TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592382TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592399TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00850310006434CrossTIE™ Reamer 2.2mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006441CrossTIE™ Reamer 2.5mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006458CrossTIE™ Reamer 2.7mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006465CrossTIE™ Reamer 3.0mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00815432028641MotoBAND CP Reamer, 2.0mmCROSSROADS EXTREMITY SYSTEMSHTO2022-11-30