FDA.report

Composix L/P Mesh with Echo PS Positioning System

Primary DI
00801741031328
Brand
Composix L/P Mesh with Echo PS Positioning System
Company
Davol Inc.
Model
0144113
Catalog number
0144113
Device description
Composix L/P Mesh with Echo PS Positioning System, Ellipse
Published
2015-07-10
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

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741031328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741031328008017410313288017410313280801741031328

GMDN Terms

TermDefinition
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbableA sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of one or more non-bioabsorbable synthetic polymers [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes

TypeValueUnit
Length13.2Inch
Width10.2Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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00801741233715GalaFLEXGP0608BDGP0608BD2025-09-25
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00801741233739GalaFLEX LITEGFLT0515BDGFLT0515BD2025-09-25
00801741233746GalaFLEX LITEGFLT0520BDGFLT0520BD2025-09-25
00801741233753GalaFLEX LITEGFLT0013BDGFLT0013BD2025-09-25
00801741233760GalaFLEX LITEGFLT1020BDGFLT1020BD2025-09-25
00801741233777GalaFLEX LITEGFLT0015BDGFLT0015BD2025-09-25
00801741233784GalaFLEX LITEGFLT0017BDGFLT0017BD2025-09-25
00801741233791GalaFLEX LITEGFLT1520BDGFLT1520BD2025-09-25
00801741233814GalaFLEX LITEGFLT0019BDGFLT0019BD2025-09-25
00801741233821GalaFLEX LITEGFLT0022BDGFLT0022BD2025-09-25
00801741233838GalaFLEX LITEGFLT0025BDGFLT0025BD2025-09-25
00801741233852GalaFLEX LITEGFLT2025BDGFLT2025BD2025-09-25
00801741234019GalaFLEX LITEGFLT2530BDGFLT2530BD2025-09-25
00801741226519Phasix123000712300072025-02-24
00801741226533Phasix123000912300092025-02-24

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