FDA.reportPublic FDA data

iSmile

Primary DI
00816419020368
Brand
iSmile
Company
Ismile Dental Products, Inc.
Model
45-2504
Catalog number
45-2504
Device description
"Sterilization Pouch 3-1/2"" x 5-1/4"""
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172280000BH Sterilization PouchBh Medical Products Co., Ltd.2018-08-03FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816419020368PrimaryGS10
20816419020362Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816419020368008164190203688164190203680816419020368
2081641902036220816419020362

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
916-928-0359info@ismiledp.com

Regulatory Flags#

DUNS number
016765988
Device count
200
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816419020078iSmile25-200325-20032023-06-21
00816419020085iSmile25-200425-20042023-06-21
00816419020771iSmile45-153645-15362024-09-27
20816419020775iSmile45-153645-15362024-09-27
00816419021532iSmile25-300125-30012023-06-21
00816419021549iSmile25-300325-30032023-06-21
00816419021556iSmile25-300525-30052023-06-21
00816419021563iSmile25-300725-30072023-06-21
00816419021570iSmile25-300225-30022023-06-21
00816419021587iSmile25-300425-30042023-06-21
00816419021594iSmile25-300625-30062023-06-21
00816419021600iSmile25-300825-30082023-06-21
00816419021617iSmile25-301025-30102023-06-21
00816419021624iSmile25-301125-30112023-06-21
00816419021853iSmile65-600565-60052023-06-21
00816419021860iSmile65-601065-60102023-06-21
00816419021877iSmile65-601565-60152023-06-21
00816419021945iSmile45-000145-00012023-06-21
00816419021952iSmile45-000245-00022023-06-21
00816419021969iSmile45-000945-00092023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
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00842942015052PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015069PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015076PRIMEDpriMED Medical Products IncFRG2026-06-04
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00842942015090PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015106PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942012990PRIMEDpriMED Medical Products IncFRG2026-05-29
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00842942013010PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013027PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013034PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013041PRIMEDpriMED Medical Products IncFRG2026-05-29