AccessGUDID - DEVICE: Micro Constrictor ®X Repair Kit (00850052601256)

GUDID

Device Identifier (DI) Information

Brand Name: Micro Constrictor ®X Repair Kit
Version or Model: AB-8700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AB-8700
Company Name: DUNAMIS MEDICAL, LLC

Primary DI Number: 00850052601256
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079471560 *Terms of Use

Device Description: Micro Constrictor ® X Repair Kit

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?
65038	Orthopaedic fixation suture button	A small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	Washer, Bolt Nut
MBI	Fastener, Fixation, Nondegradable, Soft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191319	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: 157260fe-dcae-4175-8aa1-0a9506c9072d
Public Version Date: September 27, 2024
Public Version Number: 1
DI Record Publish Date: September 19, 2024