FDA.reportPublic FDA data

XENMATRIX

Primary DI
00801741074202
Brand
XENMATRIX
Company
Davol Inc.
Model
1150808
Catalog number
1150808
Device description
XenMatrix AB Surgical Graft, 8 cm x 8 cm
Published
2014-10-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical
OXHMesh, surgical, collagen, plastic and reconstructive surgery
PIJCollagen surgical mesh containing drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
OXHMesh, Surgical, Collagen, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2
PIJCollagen Surgical Mesh Containing DrugsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133223000XENMATRIX AB SURGICAL GRAFTC.R. Bard, Inc.2014-09-19PIJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741074202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741074202008017410742028017410742020801741074202

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, collagen, antimicrobialA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it includes a pharmaceutical antibacterial agent. It may also be used as a short-term scaffold for tissue regeneration; it is not designed specifically for diaphragmatic hernia repair and has no extra-abdominal applications. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter
Width8Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius

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
Combination product
true
Lot or batch
true
Expiration date on label
true

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

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