PuraForce™
Basic Information
- Brand Name
- PuraForce™
- Primary DI
- 00618474000220
- Version / Model
- 550-006
- Company Name
- ORGANOGENESIS INC.
- Labeler DUNS
- 152165817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-17
- Public Version
- 2
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- 30b4fe23-ee0e-4558-acf0-de9547ebc6db
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Dressing, Wound, Collagen | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Collagen wound matrix dressing | A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00618474000220 | GS1 |
Customer Contacts
- Phone
- 1-888-432-5232
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042809 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 9 | Centimeter | |
| Length | 6.5 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose the device to temperatures greater than 120 Degrees Fahrenheit and less than -4 Degrees Fahrenheit.
- Type
- Special Storage Condition, Specify
- Special Conditions
- The device should be stored in a clean, dry location at room temperature.