FDA UDI
In Commercial Distribution
🇺🇸 United States
BEAR Implant (Bridge-Enhanced ACL Restoration)
DI: 00860002987804
·
Model: 1000
·
Miach Orthopaedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BEAR Implant (Bridge-Enhanced ACL Restoration)
- Primary DI
- 00860002987804
- Version / Model
- 1000
- Company Name
- Miach Orthopaedics, Inc.
- Labeler DUNS
- 016027522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-15
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 657c2912-6ceb-415a-ba37-7cf2a23a31bc
Device Description
Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
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 |
|---|---|---|---|---|
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | Orthopedic | 888.3044 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56297 | Joint cartilage biomatrix implant | A bioabsorbable animal-derived material intended to be implanted in the void of a cartilage defect of a joint (e.g., knee, ankle, shoulder), typically up to a diameter of 34 mm, during an orthopaedic or traumatologic intervention, to promote the ingrowth of autologous cells (e.g., with bone marrow stimulation techniques) for cartilage reconstruction or augmentation. It consists primarily of an animal-derived matrix structure (e.g., made of animal-derived type 1 collagen, chitosan) that provides a scaffold for cell growth. It is available in various dimensions or may be an injectable fluid, and can be applied arthroscopically, or with miniarthrotomy for larger defects. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860002987804 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200035 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius