AccessGUDID - DEVICE: BoneMedik-DM 1.0~2.0mm, 0.25g (08806387897187)

GUDID

Device Identifier (DI) Information

Brand Name: BoneMedik-DM 1.0~2.0mm, 0.25g
Version or Model: 9718
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Meta Biomed Co., Ltd.

Primary DI Number: 08806387897187
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688322841 *Terms of Use

Device Description: BoneMedik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.

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?
47698	Tungsten-weighted oesophageal dilator	A surgical instrument in the form of a strong-walled rubber tube filled with tungsten (W) designed to dilate the oesophagus using a single dilator, or dilators of sequentially increasing sizes. The device is internally weighted with the tungsten for gravity assistance [and to avoid the potential hazards of manipulation with mercury (Hg)] when blindly inserted into the oesophagus of an upright patient; it may have a round or fine tip increasing to full diameter over several centimeters from the tip. The device is commonly referred to as a Maloney or Hurst dilator and is intended to treat cardiospasm, oesophagitis, and stenosis. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone Grafting Material, Synthetic
NPM	Bone Grafting Material, Animal Source

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080772	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: 2de0bacd-8ff8-4fee-bb53-8ff1685a00d3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016