AccessGUDID - DEVICE: Biotrol (00302730000030)

GUDID

Device Identifier (DI) Information

Brand Name: Biotrol
Version or Model: DOCW06-100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DOCW06-100
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302730000030
Issuing Agency: GS1
Commercial Distribution End Date: April 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: OPTI-CIDE WIPES, 100 ct - Disinfectant (BIOTROL)

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:	Yes
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?
58077	Medical device cleaning/disinfection wipe	A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, medical devices

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 47ca2c06-4cae-41d1-bc7d-9cc7b730e5f4
Public Version Date: April 15, 2024
Public Version Number: 3
DI Record Publish Date: October 16, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10302730000037	100	00302730000030	2024-04-12	Not in Commercial Distribution	Tub - Canister
20302730000034	6	10302730000037	2024-04-12	Not in Commercial Distribution	Case