FDA.reportPublic FDA data

Pure Graft Fat Lock System

Primary DI
03701139700249
Brand
Pure Graft Fat Lock System
Company
Promepla
Model
FLS-5US
Published
2020-05-06
Public version status
New
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
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701139700249PackageGS15In Commercial Distribution
03701139700232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701139700249037011397002493701139700249
03701139700232037011397002323701139700232

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401020409
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700512905059Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512905073Irrigation TubeOSG03499ST35C8237522024-10-24
03700512905196Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512925064Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512925071Irrigation TubeOSG03499ST35C8237522024-10-24
03700512915263Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512901969Y-CLIC ADAPTER09-0197ROMYCLICST2282018-08-20
03700512963592BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmROUS1235STROUS1235ST2016-10-03
03700512963608BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmROUS1045STROUS1045ST2016-10-03
03700512963615BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmROUS1245STROUS1245ST2016-10-03
03700512965589RocaFlex Access Sheath & Dilation Catheter 10/12x35cmAS101235AS1012352016-09-14
03700512965596RocaFlex Access Sheath & Dilation Catheter 12/14x35cmAS101245AS1012452016-09-14
03700512965602RocaFlex Access Sheath & Dilation Catheter 10/12x45cmAS121435AS1214352016-09-14
03700512965619RocaFlex Access Sheath & Dilation Catheter 12/14x45cmAS121445AS1214452016-09-14
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm09-0015ROUS1035ST2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm09-0016ROUS1235ST2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm09-0017ROUS1045ST2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm09-0018ROUS1245ST2017-11-09
03700512967453LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire09-0124ROJS9522ST2282018-08-20
03700512967460LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire09-0125ROJS9524ST2282018-08-20

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