FDA.reportPublic FDA data

NA

Primary DI
10886982068798
Brand
NA
Company
Synthes GmbH
Model
03.010.438S
Catalog number
03010438S
Device description
14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
10886982068798PrimaryGS10
H67903010438S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698206879810886982068798

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, single-useA sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
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