AccessGUDID - DEVICE: Impression Coping (08806388253883)

GUDID

Device Identifier (DI) Information

Brand Name: Impression Coping
Version or Model: STTIM4511NH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STTIM4511NH
Company Name: Megagen Implant Co. Ltd

Primary DI Number: 08806388253883
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687388178 *Terms of Use

Device Description: ST Internal Implant System Impression Coping Ø4.5/ L=11/ Transfer/ Mini/ Non-hex

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?
64321	Dental precision attachment simulator/analog, single-use	A device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: ea50c382-df16-4af7-acec-2e01efa5cad7
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023