FDA.reportPublic FDA data

RMH3 DENTAL

Primary DI
06977153532051
Brand
RMH3 DENTAL
Company
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
Model
90mm×260mm
Published
2024-09-12
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
16977153530047PackageGS110In Commercial Distribution
06977153532051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697715353004716977153530047
06977153532051069771535320516977153532051

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
26977153530006RMH3 DENTAL90mmx280mm2025-12-20
16977153530009RMH3 DENTAL90mmx230mm2024-12-11
16977153530016RMH3 DENTAL57mm×130mm2024-09-12
16977153530023RMH3 DENTAL90mm×165mm2024-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535037654Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
08404535037685Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
00724995239985V. MuellerSteris CorporationFRG2026-10-15
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20884389188269GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188256GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190426GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190453GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115498GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188270GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190440GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389188283GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190484GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115597GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
10884389192481GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196180810GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921093GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921116GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190419GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277115580GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190471GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26