AccessGUDID - DEVICE: SCHWERT (E896330530S06E0)

GUDID

Device Identifier (DI) Information

Brand Name: SCHWERT
Version or Model: 3305-30S-06E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3305-30S-06E
Company Name: A. Schweickhardt GmbH & Co. KG

Primary DI Number: E896330530S06E0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341195628 *Terms of Use

Device Description: Scaler for front teeth, exchangable tips in Schwert ERGO handle green

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
41660	Periodontal curette	A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMS	CURETTE, 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: 49f675a0-e6c6-4177-a62e-66d98ffc8c93
Public Version Date: July 04, 2024
Public Version Number: 1
DI Record Publish Date: June 26, 2024