AccessGUDID - DEVICE: Anew Implant System (07350081495121)

GUDID

Device Identifier (DI) Information

Brand Name: Anew Implant System
Version or Model: ST-24M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dentatus AB

Primary DI Number: 07350081495121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355803412 *Terms of Use

Device Description: Dentatus Anew Implant, blister pack including 1 pc

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?
42354	Transgingival implant	A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

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

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: 0a5fb38d-4146-4564-9348-5ecb7f43712e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 20, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07350081494759	2	07350081495121		In Commercial Distribution	Implant pack
07350081494766	1	07350081495121		In Commercial Distribution	Implant pack

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +46854650900
Email: info@dentatus.se

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

FDA TOOLS & RESOURCES