FDA.reportPublic FDA data

Dentek

Primary DI
00311917190143
Brand
Dentek
Company
WALGREEN CO.
Model
00015101203I2
Device description
Walgreens Upper Mouth Gaurd 2 ct
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBRMouthguard, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBRMouthguard, Over-The-CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20311917190147PackageGS11In Commercial Distribution
00311917190143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2031191719014720311917190147
00311917190143003119171901433119171901430311917190143

GMDN Terms#

Term, Definition table
TermDefinition
Urological operating table, hydraulicA mobile table powered by manually-operated hydraulic mechanisms designed to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Commonly known as a transurethral resection (TUR) table, its surface consists of a flat section with a headrest; it includes adjustable leg holders/stirrups either directly attached to the table or to its side rails. It may also include traction handles and an integrated urine/irrigation fluid collection tray with a filter to catch urinary stones and/or stone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-6835xx@xx.xx
800-433-6835consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08
00311917085753Walgreens7208922026-05-08
00311917085760Walgreens7208972026-05-08
00311917077598Walgreens7377342026-04-28
00311917151434Walgreens2205442019-11-29
00311917151472Walgreens2205502019-11-28
00311917219288Walgreens2729422020-11-26
00311917219295Walgreens2729432020-11-26
00311917064635Walgreens351587 2025-06-20
00311917006239Walgreens2964622023-01-25
00311917065724Walgreens8246332025-04-29
00311917065731Walgreens8246322025-04-29
00311917065762WALGREENS8416972025-04-29
00311917065779WALGREENS7456072025-04-29
00311917066585WALGREENS8360682025-04-29

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00860014754609Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860015217721enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
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00651080651523PlackersRANIR, LLCOBR2024-04-26
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00692121035216SleepRightSplintek Inc.OBR2023-08-30
00866618000036GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000043GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18