FDA.reportPublic FDA data

Simelo

Primary DI
06977153530071
Brand
Simelo
Company
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
Model
255mm×380mm
Published
2024-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K193561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193561000Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel PouchWeihai Xingtai Packaging Products Co., Ltd.2020-04-15FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977153530071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977153530071069771535300716977153530071

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541834823
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977153530163Baylab57mm×133mm2026-04-09
06977153530170Baylab70mmx260mm2026-04-09
06977153530187Baylab89mm×165mm2026-04-09
06977153530194Baylab89mm×260mm2026-04-09
06977153530200Baylab133mmx285mm2026-04-09
06977153530217Baylab190mm×361mm2026-04-09
06977153530224Baylab266mmx514mm2026-04-09
06977153530101RMH3 DENTAL90mmx280mm2025-12-20
06977153530095RMH3 DENTAL90mm x 195mm2025-05-28
06977153532075RMH3 DENTAL135mm*260mm2024-12-16
06977153530033RMH3 DENTAL90mm×130mm2024-12-13
06977153532037RMH3 DENTAL70mm×260mm2024-12-13
06977153532044RMH3 DENTAL90mm×165mm2024-12-13
06977153530040RMH3 DENTAL90mmx230mm2024-12-11
06977153530026RMH3 DENTAL133m×279mm2024-09-12
06977153532013RMH3 DENTAL57mm×130mm2024-09-12
06977153532051RMH3 DENTAL90mm×260mm2024-09-12
26977153530006RMH3 DENTAL90mmx280mm2025-12-20
16977153530009RMH3 DENTAL90mmx230mm2024-12-11
16977153530016RMH3 DENTAL57mm×130mm2024-09-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
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00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
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00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04