FDA.report

NA

Primary DI
07611819784079
Brand
NA
Company
Synthes GmbH
Model
03.010.034S
Catalog number
03010034S
Device description
13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM-STER
Published
2018-09-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
HTWBIT, DRILL

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611819784079Direct MarkingGS10
10886982067067PrimaryGS10
10886982067074PrimaryGS10
H679030100340SecondaryHIBCC0
H67903010034S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611819784079076118197840797611819784079
1088698206706710886982067067
1088698206707410886982067074

GMDN Terms

TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
486711679
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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