AccessGUDID - DEVICE: ASTRA TECH Implant System® EV (07392532143748)

GUDID

Brand Name: ASTRA TECH Implant System® EV
Version or Model: 25347
Catalog Number: 25347
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: 07392532143748
Issuing Agency: GS1
Device Count: 1

Device Description: Direct EV API™ Ø 4

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Intramucosal dental implant	A sterile device made of alloplastic materials intended to be surgically implanted into the soft-tissue lining of the oral cavity (intramucosal insert) to provide support and a means of retention for a dental prosthesis (typically removable dentures).

Product Code	Product Code Name
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling
Special Storage Condition, Specify: Storage in the original packaging, in a dry place, at normal room temperature.

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: October 24, 2015
Commercial Distribution End Date:

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

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

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

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

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

Phone: +1(800)531-3481
Email: implants-na-cs@dentsply.com