Valved Tearaway Introducer Set

Primary DI
20841268108152
Brand
Valved Tearaway Introducer Set
Company
GALT MEDICAL CORP.
Model
VTI-010-10
Catalog number
VTI-010-10
Device description
Valved Tearaway Introducer Set
Published
2018-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268108155PackageGS110In Commercial Distribution
20841268108152PackageGS1100In Commercial Distribution
00841268108158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810815510841268108155
2084126810815220841268108152
00841268108158008412681081588412681081580841268108158

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-639-2800customerservice@galtneedletech.com

Regulatory Flags#

DUNS number
943156836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841268100855GuidewireSGW-019-38SGW-019-382017-07-03
00841268100862GuidewireSGW-019-40SGW-019-402017-07-03
00841268100879GuidewireSGW-019-41SGW-019-412017-07-03
00841268100886GuidewireSGW-019-52SGW-019-522017-07-03
00841268100893GuidewireSGW-019-53SGW-019-532017-07-03
00841268100909GuidewireSGW-021-02SGW-021-022017-07-03
00841268100916GuidewireSGW-021-03SGW-021-032017-07-03
00841268100923GuidewireSGW-021-04SGW-021-042017-07-03
00841268100930GuidewireSGW-022-09SGW-022-092017-07-03
00841268100947GuidewireSGW-022-10SGW-022-102017-07-03
00841268100954GuidewireSGW-022-11SGW-022-112017-07-03
00841268100961GuidewireSGW-022-13SGW-022-132017-07-03
00841268100978GuidewireSGW-022-14SGW-022-142017-07-03
00841268100985GuidewireSGW-022-15SGW-022-152017-07-03
00841268100992GuidewireSGW-022-16SGW-022-162017-07-03
00841268101005GuidewireSGW-022-32SGW-022-322017-07-03
00841268101012GuidewireSGW-022-33SGW-022-332017-07-03
00841268101029GuidewireSGW-022-36SGW-022-362017-07-03
00841268101036Guidewire SGW-022-49SGW-022-492017-07-03
00841268101043GuidewireSGW-035-00SGW-035-002017-07-03

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