AccessGUDID - DEVICE: MC-Subtalar™ II (04048266163035)

GUDID

Device Identifier (DI) Information

Brand Name: MC-Subtalar™ II
Version or Model: 8 35 T20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FH39358S
Company Name: Merete GmbH

Primary DI Number: 04048266163035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313267265 *Terms of Use

Device Description: MC-Subtalar™ II Screw 8 35 T20 stainless steel

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Subtalar implant, non-bioabsorbable, sterile	A sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).

FDA Product Code

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Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160548	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

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Size Type Text
Length: 35 Millimeter
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 875201ce-d509-4334-bee8-4a33bbe993f7
Public Version Date: August 01, 2018
Public Version Number: 4
DI Record Publish Date: June 10, 2016