FDA.reportPublic FDA data

NA

Primary DI
10886982263094
Brand
NA
Company
Synthes GmbH
Model
SD03.501.001
Catalog number
SD03501001
Device description
PLATE CLAMP
Published
2017-02-22
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
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982263094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698226309410886982263094

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. 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
486711679
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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
05055445928780SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928797SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928803SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928810SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928827SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928834SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928841SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
04719846011786CharderCHARDER ELECTRONIC CO., LTD.FTY2026-04-29
00190776418724MillenniumAvalign Technologies, Inc.FTY2026-04-09
00757770413607Bausch + LombBausch & Lomb IncorporatedFTY2026-03-31
00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108027Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108034Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108041Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108058Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108065Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108096Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
04946585251672CROWNJUN Micro ScaleKONO SEISAKUSHO CO.,LTD.FTY2024-11-14
14026704920553KMEDICTELEFLEX INCORPORATEDFTY2024-07-15