FDA.report

Peri-Strips Dry with Veritas Collagen Matrix

Primary DI
00085412531663
Brand
Peri-Strips Dry with Veritas Collagen Matrix
Company
SYNOVIS LIFE TECHNOLOGIES, INC.
Model
PSD6002UDSTV
Catalog number
PSD6002UDSTV
Device description
Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.
Published
2015-10-05
Public version status
Update
Distribution status
Not 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
FTMMesh, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00085412531663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00085412531663000854125316630854125316630085412531663

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.

Sterilization Methods

Method

Contacts

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
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50085412658686Peri-Strips Dry with VeritasPSDA45GIAPSDA45GIA2024-11-21
50085412658839Peri-Strips Dry with VeritasPSDA45GIATHNPSDA45GIATHN2024-11-21
00085412818313Supple Peri-GuardSPG0608SPG06082023-05-15
00085412818375Supple Peri-GuardSPG0814SPG08142023-05-15
00085412818405Peri-GuardPG0404PG04042023-05-15
00085412818429Supple Peri-GuardSPG1016SPG10162023-05-15
00085412818443Peri-GuardPG0608PG06082023-05-15
00085412818597Peri-GuardPG0814PG08142023-05-15
00085412818610Peri-GuardPG1016PG10162023-05-15
00085412818658Peri-GuardPG1225PG12252023-05-15
00085412818672Supple Peri-GuardSPG0404SPG04042023-05-15
00085412818696Supple Peri-GuardSPG0406SPG04062023-05-15
00085412818474Vascu-GuardVG0106VG01062022-11-28
00085412818498Vascu-GuardVG0108VG01082022-11-28
00085412818511Vascu-GuardVG0110VG01102022-11-28
00085412818535Vascu-GuardVG0114VG01142022-11-28
00085412818559Vascu-GuardVG01510VG015102022-11-28
00085412818573Vascu-GuardVG0209VG02092022-11-28
00085412818634Vascu-GuardVG02515VG025152022-11-28
50085412658785PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPPSDA60GIAPSDA60GIA2021-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.FTM2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.FTM2026-03-24
09421908222409Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222423Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222447Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
00850047730305Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850038226008InvengenxTisgenx, Inc.FTM2025-05-28
00850038226015InvengenxTisgenx, Inc.FTM2025-05-28
00850038226022InvengenxTisgenx, Inc.FTM2025-05-28
00850038226039InvengenxTisgenx, Inc.FTM2025-05-28
00850038226046InvengenxTisgenx, Inc.FTM2025-05-28
00850038226053InvengenxTisgenx, Inc.FTM2025-05-28
00850038226060InvengenxTisgenx, Inc.FTM2025-05-28
00850038226077InvengenxTisgenx, Inc.FTM2025-05-28
00850038226084InvengenxTisgenx, Inc.FTM2025-05-28
00850038226091InvengenxTisgenx, Inc.FTM2025-05-28