AccessGUDID - DEVICE: SMALL BONE FIXATION SYSTEM (00887868072574)

GUDID

Device Identifier (DI) Information

Brand Name: SMALL BONE FIXATION SYSTEM
Version or Model: SBFS062
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SBFS062
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868072574
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: 1.6mm SS Nail, 1 Locking Device, 1 End Cap, 1 Bending Tool, 1 Awl

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:	Yes
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?
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth
HRS	Plate, Fixation, Bone
HSB	Rod, Fixation, Intramedullary And Accessories
HTN	Washer, Bolt Nut
HWC	Screw, Fixation, Bone
JDW	Pin, Fixation, Threaded
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.1mm SS Nail, 1 Locking Device, 1 End Cap, 1 Bending Tool, 1 Awl

Device Record Status

Public Device Record Key: cbe0b9c5-ec3b-4b1e-a19c-282ae13a638b
Public Version Date: September 18, 2023
Public Version Number: 6
DI Record Publish Date: October 21, 2015