FDA.reportPublic FDA data

VascuLoop

Primary DI
00803622130847
Brand
VascuLoop
Company
LIVANOVA USA, INC.
Model
VascuLoop
Published
2016-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122735000SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2Sorin Group USA, Inc.2013-05-21GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622130844PackageGS112In Commercial Distribution
00803622130847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362213084410803622130844
00803622130847008036221308478036221308470803622130847

Regulatory Flags#

DUNS number
080914995
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622146947Vascular Dilator Kit200-1202020-08-19
00803622112522Vascular Dilator Kit200-1202014-12-22
00803622164965Perfusion PackPerfusion Pack2026-10-22
00803622164804Perfusion PackPerfusion Pack2026-10-19
00803622164811Perfusion PackPerfusion Pack2026-10-19
00803622164842Perfusion PackPerfusion Pack2026-10-19
00803622164910Perfusion PackPerfusion Pack2026-10-19
00803622164927Perfusion PackPerfusion Pack2026-10-19
00803622164934Perfusion PackPerfusion Pack2026-10-19
00803622164941Perfusion PackPerfusion Pack2026-10-19
00803622164958Perfusion PackPerfusion Pack2026-10-19
00803622164989Perfusion PackPerfusion Pack2026-10-19
00803622164996Perfusion PackPerfusion Pack2026-10-19
00803622165047Perfusion PackPerfusion Pack2026-10-19
00803622165054Perfusion PackPerfusion Pack2026-10-19
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653900497PremicronB BRAUN SURGICAL SAGAT2015-11-11
04038653914050PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653921980PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991822PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003853PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003914PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003921PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439020690PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991785PremicronB BRAUN SURGICAL SAGAT2015-11-05
10884521072657V-LocCovidien LPGAT2015-09-02
04038653983919PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653983544PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653750337PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653750450PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653871230PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900480PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900695PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900701PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900725PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653911035PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653922246PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439000944PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439001002PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439059072PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900503PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900510PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900732PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653988402PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653951048PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900541PremicronB BRAUN SURGICAL SAGAT2015-08-26