FDA.reportPublic FDA data

MatrixMANDIBLE

Primary DI
H980SD3982030
Brand
MatrixMANDIBLE
Company
SYNTHES (U.S.A.) LP
Model
SD398.203
Catalog number
SD398203
Device description
2.0MM CAPS - MATRIXMANDIBLE
Published
2016-12-31
Public version status
Update
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
20887587003037PrimaryGS10
H980SD3982030SecondaryHIBCC0
80887587003039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088758700303720887587003037
8088758700303980887587003039

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA surgical instrument designed to grasp and hold a bone during a surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. 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
2
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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