FDA.reportPublic FDA data

ERMIS

Primary DI
04049224294747
Brand
ERMIS
Company
Ermis MedTech GmbH
Model
ER200.030BA
Catalog number
ER200.030BA
Device description
3/4 Premium Lid perforated, red, 462x280 mm, barrier system
Published
2025-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049224294747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049224294747040492242947474049224294747

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974619648570info@ermis-medizintechnik.de

Regulatory Flags#

DUNS number
313118522
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14049224486972ERMISER804.090ER804.0902025-10-07
04049224270765ERMISER800.000ER800.0002025-10-07
04049224270802ERMISER800.020ER800.0202025-10-07
04049224270901ERMISER802.000ER802.0002025-10-07
04049224270932ERMISER802.020ER802.0202025-10-07
04049224271359ERMISER805.020ER805.0202025-10-07
04049224288685ERMISER800.000EER800.000E2025-10-07
04049224288692ERMISER802.000EER802.000E2025-10-07
04049224288784ERMISER800.020PER800.020P2025-10-07
04049224289217ERMISER300.040TBER300.040TB2025-10-07
04049224289224ERMISER100.040TBER100.040TB2025-10-07
04049224291036ERMISER300.010TBER300.010TB2025-10-07
04049224293375ERMISER100.010PAER100.010PA2025-10-07
04049224293382ERMISER100.020PAER100.020PA2025-10-07
04049224293399ERMISER100.030PAER100.030PA2025-10-07
04049224293405ERMISER100.040PAER100.040PA2025-10-07
04049224293412ERMISER100.050PAER100.050PA2025-10-07
04049224293429ERMISER100.060PAER100.060PA2025-10-07
04049224293436ERMISER100.060VAER100.060VA2025-10-07
04049224293443ERMISER100.010VAER100.010VA2025-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436193MillenniumAvalign Technologies, Inc.KCT2026-10-08
00385640094870INSTRUSAFESummit Medical, Inc.KCT2026-10-08
00385640094832INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094849INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094856INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094863INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094795INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094801INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094818INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094825INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094726INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094733INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094740INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094757INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094764INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094771INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094788INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00724995238360V. MuellerSteris CorporationKCT2026-10-05
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094580INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094597INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094603INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094610INSTRUSAFESummit Medical, Inc.KCT2026-09-29
00385640094627INSTRUSAFESummit Medical, Inc.KCT2026-09-29