FDA.report

NA

Primary DI
10886982300515
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
SD393.104
Catalog number
SD393104
Device description
AUTO-ADJUSTING DRIVE ADAPTOR FOR 4.0/5.0/6.0 SCHANZ SCREWS
Published
2020-07-31
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
GFCDRIVER, SURGICAL, PIN

Product Code Classifications

CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886982300515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088698230051510886982300515

GMDN Terms

TermDefinition
Manual surgical rotary handpieceA manually-powered, hand-held, surgical device intended to be used to generate a rotary motion to an endpiece during a surgical procedure for e.g., cutting, sculpting, trepanning, drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon holding the top of the brace steady whilst rotating it with horizontal crankshaft-like movements with the other hand; or 2) a drill powered by the rotation of a side-mounted, handle; it may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. 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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