FDA.reportPublic FDA data

EVSRF Procedure Pack

Primary DI
40858254006365
Brand
EVSRF Procedure Pack
Company
VENCLOSE INC
Model
VC-PP-EVSRF
Device description
Venclose procedure pack - convenient kit.
Published
2018-01-21
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

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40858254006365PackageGS15In Commercial Distribution
10858254006364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4085825400636540858254006365
1085825400636410858254006364

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085838983
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858254006008Venclose System EVSRF CatheterVC10A256F602016-11-01
00858254006015Venclose System EVSRF CatheterVC10A256F1002016-11-01
00858254006022Venclose System digiRF GeneratorVCRFG12016-11-01
00858254006046Venclose System Power CordVCPCB2016-11-01
00858254006053Venclose System Power CordVCPCE2016-11-01
00858254006060Venclose System Power CordVCPCG2016-11-01
00858254006077Venclose System Power CordVCPCC2016-11-01
00858254006084Venclose System Power CordVCPCI2016-11-01
00858254006091Venclose System Power CordVCPCN2016-11-01
00858254006107Venclose System Power CordVCPCL2016-11-01
00858254006114Venclose System Power CordVCPCK2016-11-01
00858254006121Venclose System Power CordVCPCM2016-11-01
00858254006138Venclose System Power CordVCPCH2016-11-01
00858254006145Venclose System Power CordVCPCJ2016-11-01
00858254006152Venclose System Power CordVCPCA2016-11-01
00858254006398Venclose Maven CatheterVC056F2021-09-01
00858254006404Venclose Maven CatheterVC056F2021-09-01
00858254006039Venclose System Foot PedalVCFP12016-11-01
00858254006169Venclose™ EVSRF™ CatheterVC-10A2.5-6F-60 [5X]2016-11-01
00858254006176Venclose™ EVSRF™ CatheterVC-10A2.5-6F-100 [5X]2016-11-01

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