FDA.report

NA

Primary DI
07611819086067
Brand
NA
Company
Synthes GmbH
Model
310.804
Catalog number
310804
Device description
CANNULATED COUNTERSINK FOR 3.0MM CANNULATED SCREWS
Published
2016-12-31
Public version status
Update
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
HWWCOUNTERSINK

Product Code Classifications

CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611819086067Direct MarkingGS10
10886982187000PrimaryGS10
H6793108040SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611819086067076118190860677611819086067
1088698218700010886982187000

GMDN Terms

TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). 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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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