AccessGUDID - DEVICE: M-SG® Star 2 (07640166515036)

GUDID

Device Identifier (DI) Information

Brand Name: M-SG® Star 2
Version or Model: 05000411
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05000411
Company Name: Cendres+Métaux SA

Primary DI Number: 07640166515036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 487506230 *Terms of Use

Device Description: M-SG® Star 2 TC for casting-on

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?
38580	Sliding dental precision attachment	A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.	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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4975c343-53c0-476b-9573-948809b37071
Public Version Date: September 14, 2023
Public Version Number: 1
DI Record Publish Date: September 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41583602000
Email: info@cmsa.ch

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES