FDA.reportPublic FDA data

Vitalitec Knot Pushers

Primary DI
00850001784498
Brand
Vitalitec Knot Pushers
Company
VITALITEC INTERNATIONAL, INC.
Model
MI-3002
Device description
Surgical Needle Holder MI-3002 (MI TC Needle Holder, cvd. Modular Handle, Standard Handle Insert, 30cm length)
Published
2018-12-13
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001784498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001784498008500017844988500017844980850001784498

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, reusableA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

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
00850044817016CYGNET Sterilization Tray VTI1020520-012023-05-01
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

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Primary DI, Brand, Company table
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