FDA.reportPublic FDA data

OPERACE

Primary DI
07610733850068
Brand
OPERACE
Company
PB SWISS TOOLS AG
Model
80006
Catalog number
80006
Device description
Accessories used together with the sterile inserts for implant screw extraction
Published
2024-09-24
Public version status
New
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07610733850068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07610733850068076107338500687610733850068

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
487856262
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
07610733850013OPERACE80001800012024-09-24
07610733850020OPERACE80002800022024-09-24
07610733850037OPERACE80003800032024-09-24
07610733850044OPERACE80004800042024-09-24
07610733850051OPERACE80005800052024-09-24
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
07610733850266OPERACE80026800262024-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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