FDA.reportPublic FDA data

Taylor Stitcher Sterilization basket

Primary DI
08051122041190
Brand
Taylor Stitcher Sterilization basket
Company
NCS LAB SRL
Model
P005_AS034_09
Device description
Surgical instrument to be used with Superelastic Transosseous Needle (STN).
Published
2022-06-09
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
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
08051122041190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051122041190080511220411908051122041190

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
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
08051122041213Taylor Stitcher Spanner 7mmP005_AS034_162022-06-09

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Primary DI, Brand, Company table
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B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
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