FDA.report

NA

Primary DI
07612334171016
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
03.043.020
Catalog number
03043020
Device description
COMPRESSION SCREW/ SHORT
Published
2020-12-10
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
HWNINSTRUMENT, COMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07612334171016Direct MarkingGS10
10886982297198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07612334171016076123341710167612334171016
1088698229719810886982297198

GMDN Terms

TermDefinition
Bone-nailing compression screwA rod-like orthopaedic surgical instrument designed to be inserted (screwed) through the insertion handle of an orthopaedic implant aiming arm to impart a force upon a proximally inserted bone nail locking screw thus creating compression on the proximal section of a fractured bone to close the fracture gap with the distal section which can then be locked into final position. It is typically made of high-grade stainless steel and has a threaded portion at the proximal end together with a head for acceptance of a screwdriver or other tool to provide the necessary rotation. It is available in a variety of lengths and is usually used when nailing the tibia or humerus. 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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07611819995796NA03.820.144038201442016-12-31
07611819943490NAE5115-7E511572017-02-20
H679E51157P09NAE5115-7PE51157P2016-12-31
10886982293060NA04.045.260040452602025-01-31
10886982293237NA04.045.230040452302025-01-31
10886982293244NA04.045.232040452322025-01-31
10886982293251NA04.045.234040452342025-01-31
10886982293268NA04.045.236040452362025-01-31
10886982293275NA04.045.238040452382025-01-31
10886982293282NA04.045.240040452402025-01-31
10886982293299NA04.045.242040452422025-01-31
10886982293305NA04.045.244040452442025-01-31
10886982293312NA04.045.246040452462025-01-31
10886982293329NA04.045.248040452482025-01-31
10886982293336NA04.045.250040452502025-01-31
10886982293343NA04.045.252040452522025-01-31
10886982293350NA04.045.254040452542025-01-31
10886982293367NA04.045.256040452562025-01-31

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