FDA.reportPublic FDA data

SmartPractice

Primary DI
00854498007382
Brand
SmartPractice
Company
Smarthealth, Inc.
Model
AL7220
Catalog number
AL7220
Device description
Finn Chamber Paper Discs, 18mm, 100/bag
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013820000FINN CHAMBER (R)Epitest Ltd. OY2002-01-30KXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854498007382PrimaryGS10
10854498007389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854498007382008544980073828544980073820854498007382
1085449800738910854498007389

GMDN Terms#

Term, Definition table
TermDefinition
Allergy testing adhesive strip, epicutaneousA band of adhesive material designed to be used for epicutaneous allergy testing. The device typically consists of a central portion containing a series of transparent discs onto which are applied potentially allergenic substances; it includes on one side a hypoallergenic pressure-sensitive adhesive for application to the skin of the patient. The device may include additional strips that can be used for labelling, to aid diagnosis of skin reactions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.

Contacts#

Phone, Email table
PhoneEmail
1-800-878-3837info@smartpractice.com

Regulatory Flags#

DUNS number
061081477
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D766406011SmartPractice40601406012016-09-08
D766SP6200181SmartPracticeSP620018SP6200182016-09-08
D766SP6200191SmartPracticeSP620019SP6200192016-09-08
00854498007108SmartPracticeAL71200AL712002020-12-02
00854498007115SmartPracticeAL71300AL713002020-12-02
00854498007146SmartPracticeAL7005AL70052020-12-02
00854498007153SmartPracticeAL7001AL70012020-12-02
00854498007160SmartPracticeAL7001PPAL7001PP2020-12-02
00854498007177SmartPracticeAL7002AL70022020-12-02
00854498007191SmartPracticeAL7000AL70002020-12-02
00854498007221SmartPracticeAL7003PPAL7003PP2020-12-02
00854498007245SmartPracticeAL7110AL71102020-12-15
00854498007269SmartPracticeAL7120PPAL7120PP2020-12-15
00854498007337SmartPracticeAL7004PPAL7004PP2020-12-02
00854498007344SmartPracticeAL7014AL70142020-12-02
00854498007351SmartPracticeAL7014PPAL7014PP2020-12-02
00854498007368SmartPracticeAL7100AL71002020-12-15
00854498007375SmartPracticeAL7210AL72102020-12-15
00854498007405SmartPracticeAL7201AL72012020-12-15
00854498007481SmartPracticeAL7012AL70122020-12-02

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Primary DI, Brand, Company table
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