FDA.report

Vitalitec Knot Pushers

Primary DI
00850001784436
Brand
Vitalitec Knot Pushers
Company
VITALITEC INTERNATIONAL, INC.
Model
0530-CSP
Device description
Surgical Knot Pushers 0530-CSP (O 5 mm, 30 cm, Closed Knot Pusher, Straight Tip)
Published
2018-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850001784436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001784436008500017844368500017844360850001784436

GMDN Terms

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

TypeValueUnit
Length30Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
508.747.6033lylehoward@aol.com

Regulatory Flags

DUNS number
121464288
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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