AccessGUDID - DEVICE: PHENOL APPLICATOR (00844505008129)

GUDID

Device Identifier (DI) Information

Brand Name: PHENOL APPLICATOR
Version or Model: 907
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Grace Medical, Inc.

Primary DI Number: 00844505008129
Issuing Agency: GS1
Commercial Distribution End Date: March 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 030849173 *Terms of Use

Device Description: PHENOL APPLICATOR

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?
64011	General-purpose absorbent tip applicator/swab, reusable	A hand-held manual device in the form of a slender handle made of metal intended to hold an absorbent material such as a cotton pledget at its distal end for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is typically used in a healthcare setting. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCJ	Applicator, Ent

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: 887dbbb7-4ab0-4375-b58f-6116119fc78d
Public Version Date: September 03, 2021
Public Version Number: 5
DI Record Publish Date: September 21, 2018