AccessGUDID - DEVICE: Pick Pack Forte (00310866002460)

GUDID

Device Identifier (DI) Information

Brand Name: Pick Pack Forte
Version or Model: 26200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PASCAL COMPANY, INC.

Primary DI Number: 00310866002460
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009260217 *Terms of Use

Device Description: Tweezers with the characteristics of the R-55 packing instrument incorporated at the tips.

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?
64164	Gingival retraction cord packing tool	A hand-held manual dental instrument designed specifically to pack a gingival retraction cord between the tooth and the gingiva during abutment preparation. It is a metallic single- or double-ended device with a spatula-like tip(s) which may have serrated edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIF	Accessories, Retractor, Dental

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
Dry Heat Sterilization
Peracetic Acid
Liquid Chemical
High-level Disinfectant

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: 998dd91c-5835-4669-bfea-7bb1b94d6e02
Public Version Date: May 25, 2022
Public Version Number: 2
DI Record Publish Date: November 03, 2021