FDA.reportPublic FDA data

XTAC

Primary DI
00810805000194
Brand
XTAC
Company
PRESERVATION SOLUTIONS INC
Model
XTAC
Device description
For temporary bridging of fascial defects where primary closure is not possible, including but not limited to, abdominal compartment syndrome.
Published
2016-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061934000XTACOsteogenics, Inc.2007-07-17FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810805000194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810805000194008108050001948108050001940810805000194

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy open-abdomen dressingA sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2627236715brader@preservationsolutions.com

Regulatory Flags#

DUNS number
090266979
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810805000139ClearIt Anti-Fog ClothPS0012016-10-22
10810805000146ClearIt Anti-Fog Kit PS0032016-10-11
00810805000026Belzer UW Cold Storage Solution BUW-5002016-10-22
00810805000040Belzer UW Cold Storage Solution BUW-0012016-10-07
00810805000071Belzer UW Cold Storage SolutionBUW-0022016-10-22
00810805000095Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
00810805000101Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
00810805000156Waters IGL Cold Storage SolutionCSS/1000/US2016-10-22
00810805000163Waters IGL Cold Storage SolutionCSS/2000/US2016-10-22
00810805000170Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
10810805000214"Retention Guard Suture Retention Plates - 3"""RG-32018-12-07
00810805000224"StarGuard Suture Retention Plates - 7"""SG-72018-12-07
00810805000231"StarGuard Suture Retention Plates - 9"""SG-92018-12-07
10810805000092Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
10810805000108Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
10810805000177Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
00810805000187Wittmann PatchEWP20402016-10-22
10810805000023Belzer UW Cold Storage Solution BUW-5002016-10-22
10810805000047Belzer UW Cold Storage Solution BUW-0012016-10-07
10810805000078Belzer UW Cold Storage SolutionBUW-0022016-10-22

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Primary DI, Brand, Company table
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09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
10884521857179ParieteneSOFRADIM PRODUCTIONFTL2025-11-08
08903837165978Surgical MeshHEALTHIUM MEDTECH LIMITEDFTL2023-08-31
09421906661552OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
09421906661569OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
10705031085978ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10705031085985ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
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09421905067539OviTex® LPRAROA BIOSURGERY LIMITEDFTL2020-03-13
10884521784086Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
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10884521784109Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
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09421905067690Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
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09421905067713Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067720Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
09421905067751Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01