FDA.reportPublic FDA data

GARYLINE

Primary DI
00661948008840
Brand
GARYLINE
Company
Garyline LLC
Model
DPCT56T
Catalog number
DPCT56T
Published
2023-10-26
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
LRRFirst Aid Kit With Drug
NXZDental Hygiene Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
EJRAgent, Polishing, Abrasive, Oral CavityDental1
JESFloss, DentalDental1
LRRFirst Aid Kit With DrugUnknownN
NXZDental Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00661948008840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00661948008840006619480088406619480088400661948008840

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
00661948004057GARYLINEWFA2WFA12023-10-19
00661948009847GARYLINEWFA1WFA12023-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818746020042Gingi-Plain Max Soft-TwistGingi PakJES2026-08-26
00818746020073Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020080Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020097Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
00818746020103Gingi-Plain Max Z-TwistGingi PakJES2026-08-26
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06942509220739OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
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06942509220777OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220784OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
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06942509220814OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220821OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
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06942509220845OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220852OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220869OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220876OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220883OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220920OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220937OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
00766588260143Watercraft First Aid Kit - 16 Poly WhiteCertified Safety Manufacturing, Inc.LRR2026-08-19