AccessGUDID - DEVICE: Straumann (07899878061021)

GUDID

Device Identifier (DI) Information

Brand Name: Straumann
Version or Model: 046.820
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 046.820
Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.

Primary DI Number: 07899878061021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 906713888 *Terms of Use

Device Description: INSTRUMENT TWEEZERS

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:	No
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?
64480	Dental implant/prosthesis handling forceps	A hand-held manual dental instrument designed for grasping and holding a dental implant and/or prosthesis (e.g., crown, bridge, screw) during its application to a patient's oral cavity. It typically has a tweezers-like design consisting of two conjoined blades with serrated tips at the working end; some types have graduated markings on the tips for gauging. It is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in various sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	INSTRUMENTS, DENTAL HAND

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: less than 40 Degrees Celsius
Special Storage Condition, Specify: Protect from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8070c9b1-e382-4df4-b3bb-2c8d2acab17f
Public Version Date: June 20, 2023
Public Version Number: 1
DI Record Publish Date: June 12, 2023