FDA.reportPublic FDA data

Taylor Stitcher Spanner 7mm

Primary DI
08051122041213
Brand
Taylor Stitcher Spanner 7mm
Company
NCS LAB SRL
Model
P005_AS034_16
Device description
Surgical instrument to be used with Superelastic Transosseous Needle (STN).
Published
2022-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051122041213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051122041213080511220412138051122041213

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

Regulatory Flags#

DUNS number
429763668
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
08051122041138Elite Spk inserterP005_AS034_132022-06-09
08051122040988GT TUNNELERGTTN00M12022-06-03
08051122041091Software web ShowmotionSHWM01SW12022-03-14
08051122040902Shoulder Pacemaker deviceSPM01M1SPM01M12021-09-01
08051122040919Shoulder Pacemaker device (wireless PC)SPM01M2SPM01M22021-09-01
08051122040926MySPM AppSPM01A1SPM01A12021-09-01
08051122040933MySPM@Home AppSPM01A2SPM01A22021-09-01
08051122040940Stand-alone mode KitSPM01K1SPM01K12021-09-01
08051122040957Wireless mode - KitSPM01K2SPM01K22021-09-01
08051122040964Wireless app mode - KitSPM01K3SPM01K32021-09-01
08051122040971Wireless app home mode - KitSPM01K4SPM01K42021-09-01
08051122041190Taylor Stitcher Sterilization basketP005_AS034_092022-06-09
08051122040698TAYLOR STITCHERP005_AS0342022-06-09
08051122041121Taylor Stitcher bodyP005_AS034_012022-06-09
08051122041145Taylor Stitcher PunchP005_AS034_032022-06-09
08051122041152Taylor Stitcher ScrewdriverP005_AS034_042022-06-09
08051122041169Taylor Stitcher Targeting systemP005_AS034_052022-06-09
08051122041176Taylor Stitcher Screw ring main bodyP005_AS034_062022-06-09
08051122041183Taylor Stitcher ScrewsP005_AS034_082022-06-09
08051122041206Taylor Stitcher HammerP005_AS034_122022-06-09

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Primary DI, Brand, Company table
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B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
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