FDA.reportPublic FDA data

Echo PS Positioning System

Primary DI
10801741077712
Brand
Echo PS Positioning System
Company
Davol Inc.
Model
5955000
Catalog number
5955000
Device description
Echo PS Positioning System Inflation Assembly
Published
2016-01-18
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
OQLMesh, surgical, deployment balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQLMesh, Surgical, Deployment BalloonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741077712PackageGS16In Commercial Distribution
00801741077715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107771210801741077712
00801741077715008017410777158017410777150801741077715

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mesh laparoscopic delivery/positioning deviceA sterile, hand-held manual surgical instrument intended to facilitate delivery and/or positioning of surgical mesh for implantation during laparoscopic surgery to repair an abdominal hernia/fascial defect. It consists of a handle with mechanical features used to deploy the mesh, and a distal section for mounting the mesh (e.g., collapsible frame or hollow tube) which is inserted through a laparoscopic port for positioning for subsequent fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags#

DUNS number
001191048
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741233279GalaFLEX 3DRFR3D02BDFR3D02BD2026-04-30
10801741233521GalaFLEX 3DSH3D02BDSH3D02BD2026-04-30
10801741234368GalaFLEX 3DSH3D04BDSH3D04BD2026-04-30
10801741234382GalaFLEX 3DSH3D06BDSH3D06BD2026-04-30
10801741234412GalaFLEX 3DRFR3D04BDFR3D04BD2026-04-30
10801741234436GalaFLEX 3DRFR3D06BDFR3D06BD2026-04-30
00801741074318OPTIFIX011312601131262015-04-16
00801741074325OPTIFIX011312701131272015-04-16
00801741233265GalaFLEX 3DRFR3D01BDFR3D01BD2026-04-30
00801741233494GalaFLEX 3DSH3D01BDSH3D01BD2026-04-30
00801741234354GalaFLEX 3DSH3D03BDSH3D03BD2026-04-30
00801741234378GalaFLEX 3DSH3D05BDSH3D05BD2026-04-30
00801741234392GalaFLEX 3DSH3D07BDSH3D07BD2026-04-30
00801741234408GalaFLEX 3DRFR3D03BDFR3D03BD2026-04-30
00801741234422GalaFLEX 3DRFR3D05BDFR3D05BD2026-04-30
00801741074431ONFLEX011541101154112015-07-17
00801741074424ONFLEX011541001154102015-07-17
00801741010507Avitene101034010103402014-09-12
00801741065323SIMPULSE006731000673102015-12-23
00801741065439SURETRANS859500085950002015-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741077715ECHO PSDavol Inc.OQL2016-01-18
03760185570336Biomesh® CA.B.S.’Air® CompositeCOUSIN BIOTECHOQL2015-10-23
03760185570343Biomesh® CA.B.S.’Air® CompositeCOUSIN BIOTECHOQL2015-10-23
03760185570374Biomesh® CA.B.S.’Air® CompositeCOUSIN BIOTECHOQL2015-10-23
00801741031328COMPOSIXDavol Inc.OQL2015-07-10
00801741031335COMPOSIXDavol Inc.OQL2015-07-10
00801741031342COMPOSIXDavol Inc.OQL2015-07-10
00801741031359COMPOSIXDavol Inc.OQL2015-07-10
00801741031366COMPOSIXDavol Inc.OQL2015-07-10
00801741031373COMPOSIXDavol Inc.OQL2015-07-10
00801741031694VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031700VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031717VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031724VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031731VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031748VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031755VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031762VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031779VENTRALIGHTDavol Inc.OQL2015-05-18
00801741031786VENTRALIGHTDavol Inc.OQL2015-05-18