Peri-Strips Dry with Veritas Collagen Matrix Circular PSD25EVBIO

GUDID 00085412531304

Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains two loading units w/buttress material, one for the anvil and one for the cartridge side of the stapler. The packaging also includes one cartridge cone to aid atraumatic advancement of the stapler into the surgical site, and one tube of PSD Gel to create a temporary bond between the buttress and the surgical stapler until the stapler is positioned and fired.

SYNOVIS LIFE TECHNOLOGIES, INC.

Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip Staple line-reinforcement strip
Primary Device ID00085412531304
NIH Device Record Key8486853d-f4d3-4ce4-9916-3f30569cb162
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeri-Strips Dry with Veritas Collagen Matrix Circular
Version Model NumberPSD25EV
Catalog NumberPSD25EVBIO
Company DUNS017415781
Company NameSYNOVIS LIFE TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature. Keep away from heat. Do not use if heat indicator is red.
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412531304 [Primary]

FDA Product Code

FTMMesh, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-05

On-Brand Devices [Peri-Strips Dry with Veritas Collagen Matrix Circular]

00085412531311Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement (PSD-V) is prepa
00085412531304Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is prepa
00085412531298Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement (PSD-V) is prepa
00085412531281Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is prepa

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.