FDA.reportPublic FDA data

NA

Primary DI
10705034700595
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
PDL426
Catalog number
PDL426
Device description
DISTRACTOR 14MM
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034700595PrimaryGS10
H981PDL426ISecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503470059510705034700595

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982027795NA02.007.000S02007000S2015-09-14
10886982066763NA03.007.020030070202016-12-31
10886982160898NA237.043S237043S2015-09-14
10886982160904NA237.044S237044S2015-09-14
10886982160928NA237.054S237054S2015-09-14
10886982160935NA237.063S237063S2015-09-14
10886982160942NA237.064S237064S2015-09-14
10886982160959NA237.083S237083S2015-09-14
10886982160966NA237.084S237084S2015-09-14
10886982160973NA237.085S237085S2015-09-14
10886982160980NA237.086S237086S2015-09-14
10886982161000NA237.104S237104S2015-09-14
10886982161017NA237.105S237105S2015-09-14
10886982161024NA237.106S237106S2015-09-14
10886982161031NA237.123S237123S2015-09-14
10886982161048NA237.124S237124S2015-09-14
10886982161055NA237.125S237125S2015-09-14
10886982162038LCP238.7002387002015-09-14
10886982162052LCP238.7012387012015-09-14
10886982162076LCP238.7022387022015-09-14

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