FDA.reportPublic FDA data

Vitalitec Shovel Retractors

Primary DI
00857987006255
Brand
Vitalitec Shovel Retractors
Company
VITALITEC INTERNATIONAL, INC.
Model
V9095
Device description
Sterilization Tray for Cygnet Clamps
Published
2018-12-11
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857987006255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857987006255008579870062558579870062550857987006255

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508.747.6033lylehoward@aol.com

Regulatory Flags#

DUNS number
121464288
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044817016CYGNET Sterilization Tray VTI1020520-012023-05-01
00850001784580Vitalitec MI Ball Point ProbeMI-70862018-12-13
00850001784528Vitalitec Surgical ScissorsMI-30332018-12-13
00850001784566Vitalitec Surgical ScissorsMI-35332018-12-13
00850001784573Vitalitec Surgical ScissorsMI-35612018-12-13
00850001784948AY Cygnet Clampvsay00064vsay000642022-08-17
00852621004697MICA AppliersPLM535-1PLM535-12022-08-17
00850001784917Vitalitec Clip AppliersPBC228PBC2282022-08-16
00850001784924Vitalitec Clip AppliersPVC328PVC3282022-08-16
00850001784931Vitalitec Clip AppliersPOC428POC4282022-08-16
00850001784955AY Cygnet ClampVSAY-LK66VSAY-LK662022-08-16
00850001784962AY Cygnet ClampVSAY-LK86VSAY-LK862022-08-16
00850001784979MICA AppliersPWM635-1PWM635-12022-08-16
00850001784986MICA AppliersPRM135-1PRM135-12022-08-16
00850001784993MICA AppliersPJM135-1PJM135-12022-08-16
00850044817009MICA AppliersPBM235-1PBM235-12022-08-16
00850001784689Vitalitec Clip AppliersPWT620PWT6202022-08-10
00850001784696Vitalitec Clip AppliersPJT120PJT1202022-08-10
00850001784702Vitalitec Clip AppliersPRT120PRT1202022-08-10
00850001784719Vitalitec Clip AppliersPLT520PLT5202022-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23
00190776422004MillenniumAvalign Technologies, Inc.FSM2026-07-23
18059015378368Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378375Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378382Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
00841731153258ARTEMIS FUZEVILEX LLCFSM2026-07-22
00841731153265ARTEMIS TAKEDOWNVILEX LLCFSM2026-07-22
B803PW12A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW14G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW18A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW20ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW22A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW26A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW30A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW32A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW40A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW6G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
00840606195737ViaductSPINAL ELEMENTS, INC.FSM2026-07-20
00843059127478LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FSM2026-07-20
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17