AccessGUDID - DEVICE: M-Fix 7mm (00860366001420)

GUDID

Device Identifier (DI) Information

Brand Name: M-Fix 7mm
Version or Model: FG3007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CORACOID SOLUTIONS LLC

Primary DI Number: 00860366001420
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073670228 *Terms of Use

Device Description: Surgical implant to reduce and stabilize the acromioclavicular joint.

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):	No
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?
62000	Acromioclavicular joint stabilization implant	A sterile implantable device intended to be used to approximate/stabilize the acromioclavicular joint to facilitate healing of a disrupted coracoclavicular ligament (i.e., the device is not intended to replace the damaged ligament). It is in the form of a cord with a loop for attachment to the coracoid process at one end, with a component for fixation to the clavicle (e.g., screw) at the other end. It may be implanted arthroscopically or during open surgery.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	Washer, Bolt Nut

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153211	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
No Device Sizes

Device Record Status

Public Device Record Key: d1e54f43-11a4-4e38-b4bf-2349fb70fd6e
Public Version Date: July 19, 2018
Public Version Number: 1
DI Record Publish Date: June 18, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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