AccessGUDID - DEVICE: NATIONAL DISTRIBUTION & CONTRACTING INC. (00840018602656)

GUDID

Device Identifier (DI) Information

Brand Name: NATIONAL DISTRIBUTION & CONTRACTING INC.
Version or Model: SPW7Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NORDENT MANUFACTURING INC

Primary DI Number: 00840018602656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053187985 *Terms of Use

Device Description: WAX SPATULA #7 QUALA

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):	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?
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAF	Spatula, Surgical, General & Plastic Surgery

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 [?]
Dry Heat Sterilization
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: 92b7e3ce-af4b-4df9-9389-f4f8ab7bd1cc
Public Version Date: May 28, 2020
Public Version Number: 1
DI Record Publish Date: May 20, 2020