FDA.reportPublic FDA data

Simelo

Primary DI
06977153532129
Brand
Simelo
Company
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
Model
190mm*360mm
Published
2024-12-16
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
06977153532129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977153532129069771535321296977153532129

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 (non-electrical) 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
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
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05
00840456201930JMUJMU DENTAL, INCFRG2026-06-05
00840456201947JMUJMU DENTAL, INCFRG2026-06-05
00840456202951JMUJMU DENTAL, INCFRG2026-06-05
00840456202968JMUJMU DENTAL, INCFRG2026-06-05
00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05