AccessGUDID - DEVICE: BEAR Implant (Bridge-Enhanced ACL Restoration) (00860002987804)

GUDID

Device Identifier (DI) Information

Brand Name: BEAR Implant (Bridge-Enhanced ACL Restoration)
Version or Model: 1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Miach Orthopaedics, Inc.

Primary DI Number: 00860002987804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016027522 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200035	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 657c2912-6ceb-415a-ba37-7cf2a23a31bc
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: October 15, 2021