FDA.reportPublic FDA data

NA

Primary DI
10886982068743
Brand
NA
Company
Synthes GmbH
Model
03.010.433
Catalog number
03010433
Device description
WIRE GUIDE/2 HOLES 12.0/3.2MM FOR SUPRAPATELLAR
Published
2015-09-14
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
JDSNAIL, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111667000SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSSynthes (Usa)2011-12-05JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819501720Direct MarkingGS10
10886982068743PrimaryGS10
H679030104330SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819501720076118195017207611819501720
1088698206874310886982068743

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982198266NA391.73391732016-12-31
10886982312259NA60.133.200601332002022-04-12
10886982312266NA60.133.300601333002022-06-17
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08905892004599GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004636GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004667GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDS2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDS2023-12-30
08905892006968GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006975GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006982GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006999GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007002GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007019GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007026GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007033GPCGPC MEDICAL LIMITEDJDS2023-11-30