FDA.reportPublic FDA data

EF1

Primary DI
00810028397859
Brand
EF1
Company
Medshape, Inc.
Model
DNE-1000-OE
Device description
Wrench - Open End
Published
2024-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXCWrench
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028397859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028397859008100283978598100283978590810028397859

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
601306413
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
M97015000009200Eclipse1500-00-09202017-02-16
M97015000004100Eclipse1500-00-04102017-05-19
M97015000004170Eclipse1500-00-04172017-02-16
M97015000005120Eclipse1500-00-05122017-05-19
M97015000005200Eclipse1500-00-05202017-05-19
M97015000006200Eclipse1500-00-06202017-05-19
M97015000007200Eclipse1500-00-07202017-05-19
M97015000008200Eclipse1500-00-08202017-05-19
00190446914020EF1DNE-1000-WFB32026-04-01
00190446914563EF1DNE-6000-0402026-04-01
00190446907374EF1911-07-00012026-03-31
00190446907381EF1911-07-00022026-03-31
00190446907404EF1912-07-00012026-03-31
00190446907411EF1912-07-00022026-03-31
00190446908333EF1913-07-00012026-03-31
00190446908340EF1913-07-00022026-03-31
00190446908357EF1913-07-00032026-03-31
00190446908364EF1913-07-00042026-03-31
00190446958987EF1911-07-00032026-03-31
00190446959533EF1911-07-00042026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692910MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692941MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002065MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002072MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002089MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002096MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002102MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08052990974535DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739536225ST.A.R. 90 F4CITIEFFE SRLKTT2019-11-29
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990972661DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974542DOLPHIXCITIEFFE SRLKTT2019-05-18