FDA.reportPublic FDA data

Peri-Strips Dry with Veritas

Primary DI
50085412658686
Brand
Peri-Strips Dry with Veritas
Company
SYNOVIS LIFE TECHNOLOGIES, INC.
Model
PSDA45GIA
Catalog number
PSDA45GIA
Device description
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
Published
2024-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXEMesh, surgical, collagen, staple line reinforcement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXEMesh, Surgical, Collagen, Staple Line ReinforcementGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213125000PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP TechnologySynovis Life Technologies. Inc. (A Subsidiary of Baxter2021-10-27FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412658686PackageGS16In Commercial Distribution
00085412658681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541265868650085412658686
00085412658681000854126586810854126586810085412658681

GMDN Terms#

Term, Definition table
TermDefinition
Staple line-reinforcement stripA sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
017415781
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
true
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
00085412531212VERITAS COLLAGEN MATRIXRM-0818RM0818BIO2015-10-05
00085412531076VERITAS COLLAGEN MATRIXRM-0208RM0208BIO2015-10-05
00085412531090VERITAS COLLAGEN MATRIXRM-0304RM0304BIO2015-10-05
00085412531113VERITAS COLLAGEN MATRIXRM-0407RM0407BIO2015-10-05
00085412531137VERITAS COLLAGEN MATRIXRM-0416RM0416BIO2015-10-05
00085412531151VERITAS COLLAGEN MATRIXRM-0608RM0608BIO2015-10-05
00085412531175VERITAS COLLAGEN MATRIXRM-0618RM0618BIO2015-10-05
00085412531199VERITAS COLLAGEN MATRIXRM-0816RM0816BIO2015-10-05
00085412531236VERITAS COLLAGEN MATRIXRM-1016RM1016BIO2015-10-05
00085412531250VERITAS COLLAGEN MATRIXRM-1212RM1212BIO2015-10-05
00085412531274VERITAS COLLAGEN MATRIXRM-1225RM1225BIO2015-10-05
00085412658681Peri-Strips Dry with VeritasPSDA45GIAPSDA45GIA2024-11-21
00085412658834Peri-Strips Dry with VeritasPSDA45GIATHNPSDA45GIATHN2024-11-21
50085412658839Peri-Strips Dry with VeritasPSDA45GIATHNPSDA45GIATHN2024-11-21
00085412818405Peri-GuardPG0404PG04042023-05-15
00085412530529Peri-GuardPC0404NPC0404NBIO2015-10-08
00085412530567Peri-GuardPC0608NPC0608NBIO2015-10-08
00085412530581Peri-GuardPC0814NPC0814NBIO2015-10-08
00085412530604Peri-GuardPC1016NPC1016NBIO2015-10-08
00085412530628Peri-GuardPC1225NPC1225NBIO2015-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OXE2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OXE2026-03-24
00812337020671Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2025-03-14
00812337020688Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2025-03-14
00085412658681Peri-Strips Dry with VeritasSYNOVIS LIFE TECHNOLOGIES, INC.OXE2024-11-21
00085412658834Peri-Strips Dry with VeritasSYNOVIS LIFE TECHNOLOGIES, INC.OXE2024-11-21
00085412658780PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2021-12-01
00085412658841PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2021-12-01
50085412658785PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2021-12-01
00085412658797PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-04-23
00085412658858PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-04-23
00085412658803PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
00085412658865PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
50085412658808PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
50085412658860PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
00812337023719TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023726TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023733TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023740TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023757TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023764TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023771TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337025300Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025317Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025324Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025331Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025348Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025355Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00827002232013BiodesignCOOK BIOTECH INCORPORATEDOXE2015-11-03
00827002236622BiodesignCOOK BIOTECH INCORPORATEDOXE2015-11-03