FDA.reportPublic FDA data

CYGNET Sterilization Tray

Primary DI
00850044817016
Brand
CYGNET Sterilization Tray
Company
VITALITEC INTERNATIONAL, INC.
Model
VTI1020520-01
Device description
Sterilization Tray for Cygnet Clamps
Published
2023-05-01
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
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
00850044817016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044817016008500448170168500448170160850044817016

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, reusableA device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/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, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857987006255Vitalitec Shovel RetractorsV90952018-12-11
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
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03