AccessGUDID - DEVICE: SIS (08806343917980)

GUDID

Device Identifier (DI) Information

Brand Name: SIS
Version or Model: SBCSR45
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shinhung MST Co., Ltd.

Primary DI Number: 08806343917980
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689667152 *Terms of Use

Device Description: This product is used to implement fixture, abutment of oral cavity in impression acquisition and work model during dental implant procedure.

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?
44881	Dental implant suprastructure kit	A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	Attachment, Precision, All

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
Storage Environment Temperature: between 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 685260ef-ee05-48b2-a92a-8aa82f34827c
Public Version Date: September 14, 2021
Public Version Number: 1
DI Record Publish Date: September 06, 2021