FDA.report

Orthopaedic Surgical Instruments

Primary DI
08032909620333
Brand
Orthopaedic Surgical Instruments
Company
CITIEFFE SRL
Model
Cannulated drill bit ø6.5mm Jacobs joint
Catalog number
50169
Published
2021-11-12
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

Related Records

Contact Domains

Product Codes

CodeName
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08032909620333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08032909620333080329096203338032909620333

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA 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 usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Dry and clean environment and avoid damaging the packing. Room temperature.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+39051721850info@citieffe.com

Regulatory Flags

DUNS number
431406875
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08059386748183ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrew ruler for drill bit L.150mmDT0720352026-02-10
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08059386742532ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 5mmFN0000052025-12-15
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