AccessGUDID - DEVICE: Plak-Vac (B23930350)

GUDID

Device Identifier (DI) Information

Brand Name: Plak-Vac
Version or Model: 3035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3035
Company Name: TRADEMARK MEDICAL, L.L.C.

Primary DI Number: B23930350
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024113805 *Terms of Use

Device Description: Plak-Vac custom kit

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:	Yes
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?
45172	Oral care kit, single-use	A collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXZ	Dental Hygiene Kit

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
Handling Environment Temperature: between 7 and 37 Degrees Celsius
Storage Environment Temperature: between 7 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 815a8be6-e329-4121-8ea3-d47a9e2f81d1
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 15, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B23930351	24	B23930350		In Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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