FDA.reportPublic FDA data

OPERACE

Primary DI
07610733850709
Brand
OPERACE
Company
PB SWISS TOOLS AG
Model
80070
Catalog number
80070
Device description
Sterile single use insert for the removal of intact 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
GXLScrewdriver, Skullplate
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07610733850709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07610733850709076107338507097610733850709

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. 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

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00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
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00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
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00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
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10887587078557NASynthes GmbHHXX2026-07-24
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00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154651LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154668LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21