AccessGUDID - DEVICE: MotoCLIP™ (00815432023127)

GUDID

Device Identifier (DI) Information

Brand Name: MotoCLIP™
Version or Model: 1412-1212
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1412-1212
Company Name: CROSSROADS EXTREMITY SYSTEMS

Primary DI Number: 00815432023127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058864308 *Terms of Use

Device Description: MotoCLIP™ is a bone staple for use in surgery of the hand and foot bone fragment osteotomy fixation and joint arthrodesis

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?
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDR	Staple, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142727	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12mm x 12mm x 12mm

Device Record Status

Public Device Record Key: 237c6670-7de9-4ca3-8545-96af54a7051f
Public Version Date: March 17, 2025
Public Version Number: 5
DI Record Publish Date: June 23, 2016