FDA.reportPublic FDA data

Sterilization tray (254 x 152 x 38 mm)

Primary DI
07640176970306
Brand
Sterilization tray (254 x 152 x 38 mm)
Company
Naviswiss AG
Model
NS030
Device description
Sterilization tray (254 x 152 x 38 mm)
Published
2024-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K193094000
K223351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193094000Naviswiss Hip Navigation SystemNaviswiss AG2020-06-10OLO
K223351000Naviswiss KneeNaviswiss AG2023-01-31OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640176970306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640176970306076401769703067640176970306

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483929829
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640176971327Sizer AdapterNS1322025-11-18
07640176970740Resection CheckerNS0742025-08-12
07640176970016Navigation unitNS0012024-05-16
07640176970023Control unitNS0022024-05-16
07640176970108Set of NAVItags (sterile, single-use)NS0102024-05-16
07640176970115Tag adapter PNS0112024-05-16
07640176970122Tag adapter M (magnetic)NS0122024-05-16
07640176970153Hex screwdriver SW3.5mm (AO coupling)NS0152024-05-16
07640176970177Tag adapter FNS0172024-05-16
07640176970191Pelvic caliperNS0192024-05-16
07640176970214Speed pin (3.0 x 80 mm, wear part)NS0212024-05-16
07640176970221Speed pin adapterNS0222024-05-16
07640176970238Cortical bone screwNS0232024-05-16
07640176970252Calibration barNS0252024-05-16
07640176970320Tag adapter M (quick-lock)NS0322024-05-16
07640176970337PointerNS0332024-05-16
07640176970375Hex screwdriver SW3.5mm spherical headNS0372024-05-16
07640176970467Cortical bone screw (self drilling, 3.5 x 23 mm, wear part)NS0462024-05-16
07640176970481Single-pin tag mount (self-drilling, wear part)NS0482024-05-16
07640176970498Single-pin tag mount AO adapterNS0492024-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD346130Surgical DirectSurgical Direct, Inc.KCT2026-08-03
B382SD500520Surgical DirectSurgical Direct, Inc.KCT2026-08-03
B382SD165270Surgical DirectSurgical Direct, Inc.KCT2026-07-31
B382SD225040Surgical DirectSurgical Direct, Inc.KCT2026-07-31
00810166521628X-PACEXPANDING INNOVATIONS, INC.KCT2026-07-30
00850001720830X-PACEXPANDING INNOVATIONS, INC.KCT2026-07-30
D7702752883INSTRUMENTS TRAY FORSWEDEN & MARTINA SPAKCT2026-07-27
D7702752893SURGICAL KITSWEDEN & MARTINA SPAKCT2026-07-27
10886705032266NAMedos International SàrlKCT2026-07-22
00190776400484MillenniumAvalign Technologies, Inc.KCT2026-07-21
00385640093323INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093484INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093491INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093507INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093514INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00763000830076Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-07-17
00653159014208CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014215CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014222CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014239CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17