FDA.report

NA

Primary DI
07611819082335
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
397.371
Catalog number
397371
Device description
BENDING IRON FOR 2.4MM PLATES (2 REQUIRED)
Published
2018-08-29
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
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications

CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611819082335Direct MarkingGS10
10887587041537PrimaryGS10
H9803973710SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611819082335076118190823357611819082335
1088758704153710887587041537

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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
832637081
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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10886982293367NA04.045.256040452562025-01-31

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