FDA.reportPublic FDA data

NA

Primary DI
10886982200235
Brand
NA
Company
Synthes GmbH
Model
395.304
Catalog number
395304
Device description
SOCKET WRENCH 5.5MM
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
JEYPLATE, BONE
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961350000
K971987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961350000SYNTHES MINI EXTERNAL FIXATORSynthes (Usa)1996-06-28KTT
K971987000SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORSynthes (Usa)1997-06-24JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819200081Direct MarkingGS10
10886982200235PrimaryGS10
H6793953040SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819200081076118192000817611819200081
1088698220023510886982200235

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. 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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
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
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
07613327370676NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370683NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370690NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370706NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370713NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370720NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370737NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370744NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370751NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370768NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370775NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370782NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370799NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370805NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370812NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370829NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370836NAStryker Leibinger GmbH & Co. KGJEY2019-01-31
07613327370843NAStryker Leibinger GmbH & Co. KGJEY2019-01-31