FDA.reportPublic FDA data

STERILIZATION TUBING

Primary DI
D89260705600470
Brand
STERILIZATION TUBING
Company
MAXILL, INC.
Model
6070560047
Published
2022-09-19
Public version status
New
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
K180661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180661000SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp.2018-06-05FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705600471PackageHIBCC36In Commercial Distribution
D89260705600470PrimaryHIBCC0

Regulatory Flags#

DUNS number
079343581
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D89260705600570AUTOCLAVE TAPE60705600572022-09-19
D89260705600580AUTOCLAVE TAPE60705600582022-09-19
D89260705600590AUTOCLAVE TAPE60705600592022-09-19
00060705811240u-test SI Steam Sterilization Integrator811242016-10-17
D89260705533181POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533182POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533191POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705533192POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705535201COVERMAX OPTIMUM HEADREST COVER60705535202022-10-20
D8926070553525BU1COVERMAX OPTIMUM HEADREST COVER6070553525BU2022-10-20
D8926070553525GN1COVERMAX OPTIMUM HEADREST COVER6070553525GN2022-10-20
D8926070553525LV1COVERMAX OPTIMUM HEADREST COVER6070553525LV2022-10-20
D89260705533601PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533602PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533611PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533612PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533621PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533622PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533651PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22
D89260705533652PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155123Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155161Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155178Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155185Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155192Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
06954454006672COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006689COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006696COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006702COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006719COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006726COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006733COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006740COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454013984COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
08404535038446Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-30
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23