AccessGUDID - DEVICE: Biosteon® IntraLine® (15060155711185)

GUDID

Device Identifier (DI) Information

Brand Name: Biosteon® IntraLine®
Version or Model: 3910-200-083
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3910-200-083
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155711185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.

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?
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: between 39 and 117 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 47 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 5.5 Millimeter

Device Record Status

Public Device Record Key: fc08abaf-5f98-4102-a780-d23bac452dc8
Public Version Date: January 03, 2024
Public Version Number: 4
DI Record Publish Date: June 30, 2015