PuraForce ™

GUDID 00618474000213

PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended for implantation to reinforce soft tissue. The device is supplied sterile in double layer peel-open packaging. The product is packaged hydrated and is ready to use. PuraForce ™ is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps or other tendons. PuraForce ™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps and quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. PuraForce reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.

ORGANOGENESIS INC.

Collagen wound matrix dressing

• Primary Device ID: 00618474000213
• NIH Device Record Key: 1fc2ced2-f935-4ee6-bee8-f40db4d8345c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraForce ™
• Version Model Number: 550-004
• Company DUNS: 152165817
• Company Name: ORGANOGENESIS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx
• Phone: 1-888-432-5232
• Email: xx@xx.xx

Device Dimensions

• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter
• Width: 3 Centimeter
• Length: 6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042809

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-07-17

Devices Manufactured by ORGANOGENESIS INC.

• 00618474000398 - PuraPly Micronized Wound Matrix (PuraPly MZ): 2023-05-09 PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds.
• 00618474000404 - PuraPly Micronized Wound Matrix (PuraPly MZ): 2023-05-09 PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds.
• 00618474000411 - PuraPly Micronized Wound Matrix (PuraPly MZ): 2023-05-09 PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds.
• 00618474000466 - PuraPly™ Antimicrobial XT Wound Matrix: 2021-12-09 PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride
• 00618474000442 - PuraPly™ Antimicrobial Wound Matrix: 2021-04-14 uraPly™ Antimicrobial Wound Matrix (fenestrated) consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochlo
• 00618474000459 - PuraPly™ Antimicrobial Wound Matrix: 2021-04-14 PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) in
• 00618474000435 - PuraPly™ Antimicrobial Wound Matrix: 2020-10-12 PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) in
• 00618474000206 - PuraForce™: 2020-05-06 PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended for implantation to reinforce soft ti