FDA.reportPublic FDA data

GARYLINE

Primary DI
00661948005351
Brand
GARYLINE
Company
Garyline LLC
Model
PZTK
Catalog number
PZTK
Published
2023-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual
EJRAgent, Polishing, Abrasive, Oral Cavity
JESFloss, Dental
NXZDental Hygiene Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
EJRAgent, Polishing, Abrasive, Oral CavityDental1
JESFloss, DentalDental1
NXZDental Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00661948005351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00661948005351006619480053516619480053510661948005351

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, reusableA 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. It's 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001619337
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00661948011796GARYLINEFA341-CCFA341-CC2024-06-25
00661948011765GARYLINECK-CONTENTS-12024-06-17
00661948011758GARYLINEHSK3A-ALTHSK3A-ALT2024-05-14
00661948011727GARYLINEDPCT64SNCT64SN2024-03-21
00661948011710GARYLINEPZ53-CK-2PZ53-CK-12024-03-05
00661948004125GARYLINEWFA6WFA62024-01-12
00661948011703GARYLINEDPFA341-NOMEDDPFA341-NOMED2024-01-11
00661948102005GARYLINEFA1239-CK-GLA052FA1239-CK-GLA0522024-01-04
00661948009922GARYLINEWFA4WFA42024-01-02
00661948011901GARYLINEWFA5WFA52024-01-02
00661948011918GARYLINEFA16-PB5FA16-PB52024-01-02
00661948004392GARYLINEWFA3WFA32023-12-18
00661948011246GARYLINEPZ600-A-CKPZ600-A-CK2023-12-14
00661948004378GARYLINEFA74FA742023-12-07
00661948004040GARYLINEDPPZTKDPPZTK2023-11-27
00661948008833GARYLINEFA340FA3402023-11-21
00661948004361GARYLINEDPPZ52DPPZ522023-11-20
00661948004385GARYLINEPZ52-CKPZ52-CK2023-11-09
00661948008840GARYLINEDPCT56TDPCT56T2023-10-26
00661948004057GARYLINEWFA2WFA12023-10-19

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Primary DI, Brand, Company table
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