FDA.reportPublic FDA data

NA

Primary DI
10887587074306
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
SD03.501.704
Catalog number
SD03501704
Device description
RIB PLATE REDUCTION ROD 10MM
Published
2018-11-06
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

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
10887587074306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758707430610887587074306

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-fragment manipulator, single-use, non-sterileA non-sterile, hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the cheek and into the mandible) and removed after positioning and fixation of the fracture. This is a single-use device intended to be sterilized prior to use.

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H981PDL432FNAPDL432PDL4322017-02-20
H981PDL434HNAPDL434PDL4342017-02-20
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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Primary DI, Brand, Company table
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00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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