FDA.reportPublic FDA data

Proximal Ulna Plate

Primary DI
00841506131894
Brand
Proximal Ulna Plate
Company
SKELETAL DYNAMICS L.L.C.
Model
Proximal Ulna Plating System, Sterilization Tray,
Catalog number
PUP-INSRT-TOP
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102103000SKELETAL DYNAMICS STERILIZATION TRAYSSkeletal Dynamics, LLC2010-12-07KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506131894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506131894008415061318948415061318940841506131894

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags#

DUNS number
869056148
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841506134895Threaded Hand NailDGA-THN-20DGA-THN-202026-04-29
00841506140193Threaded Hand NailDRVR-UQC-T8RDRVR-UQC-T8R2026-04-29
00841506140216Threaded Hand NailDRVR-CAN-T10RDRVR-CAN-T10R2026-04-29
00841506140223Threaded Hand NailDRVR-CAN-T8RDRVR-CAN-T8R2026-04-29
00841506141060Threaded Hand NailKWIR-DT-14171KWIR-DT-141712026-04-29
00841506141398Threaded Hand NailHTS-WPHTS-WP2026-04-29
00841506141428Threaded Hand NailKWIR-ST-07152KWIR-ST-071522026-04-29
00841506146546Threaded Hand NailRHS-20012CRHS-20012C2026-04-29
00841506146553Threaded Hand NailRHS-20014CRHS-20014C2026-04-29
00841506146560Threaded Hand NailRHS-20016CRHS-20016C2026-04-29
00841506146577Threaded Hand NailRHS-20018CRHS-20018C2026-04-29
00841506146584Threaded Hand NailRHS-20020CRHS-20020C2026-04-29
00841506146591Threaded Hand NailRHS-20022CRHS-20022C2026-04-29
00841506146607Threaded Hand NailRHS-20024CRHS-20024C2026-04-29
00841506146614Threaded Hand NailRHS-20026CRHS-20026C2026-04-29
00841506146621Threaded Hand NailRHS-20028CRHS-20028C2026-04-29
00841506146638Threaded Hand NailRHS-20032CRHS-20032C2026-04-29
00841506146645Threaded Hand NailRHS-20036CRHS-20036C2026-04-29
00841506146652Threaded Hand NailRHS-20040CRHS-20040C2026-04-29
00841506146669Threaded Hand NailRHS-20044CRHS-20044C2026-04-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22
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00642356006222Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006239Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006246Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006253SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006260SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006277SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006284SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006291SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006345SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006352SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006369SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006376SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006383SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006390SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006406SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006413SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006420SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006437SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006444SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006451SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006468SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006475SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006482SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006499SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006505SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006512SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006529SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006536SteriBestMastel Surgical Inc.KCT2026-10-22