AccessGUDID - DEVICE: devemed (04061644039616)

GUDID

Device Identifier (DI) Information

Brand Name: devemed
Version or Model: 2525-40 FT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: devemed GmbH

Primary DI Number: 04061644039616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 506826739 *Terms of Use

Device Description: TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm F-LINE | SL | single ended

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?
31848	Periodontal probe, reusable	A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EIX	Probe, Periodontic

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 432e10a1-db25-4770-81fe-4c77ced7d523
Public Version Date: April 27, 2020
Public Version Number: 1
DI Record Publish Date: April 17, 2020