FDA.reportPublic FDA data

Peri-Strips Dry with Veritas Collagen Matrix Circular

Primary DI
00085412531311
Brand
Peri-Strips Dry with Veritas Collagen Matrix Circular
Company
SYNOVIS LIFE TECHNOLOGIES, INC.
Model
PSD25V
Catalog number
PSD25V
Device description
Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains a buttress assembly with two (2) circular buttresses, one for the anvil and one for the cartridge side of the stapler. Each buttress assembly has a coating of acrylic adhesive on one side for attachment to the stapler surfaces. The packaging also includes one cartridge cone to aid atraumatic advancement of the stapler into the surgical site.
Published
2015-10-05
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085412531311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085412531311000854125313110854125313110085412531311

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

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
Lot or batch
true
Expiration date on label
true

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
50085412658686Peri-Strips Dry with VeritasPSDA45GIAPSDA45GIA2024-11-21
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

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