FDA.reportPublic FDA data

ERMIS

Primary DI
04049224294600
Brand
ERMIS
Company
Ermis MedTech GmbH
Model
ER200.010PA
Catalog number
ER200.010PA
Device description
3/4 Premium Lid perforated, silver, 462x280 mm, PTFE 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
04049224294600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049224294600040492242946004049224294600

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
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24
00724995237080V. MuellerSteris CorporationKCT2026-09-24
00724995237097V. MuellerSteris CorporationKCT2026-09-24
00724995237103V. MuellerSteris CorporationKCT2026-09-24
00724995237110V. MuellerSteris CorporationKCT2026-09-24
00724995237127V. MuellerSteris CorporationKCT2026-09-24
00724995237134V. MuellerSteris CorporationKCT2026-09-24
00724995237141V. MuellerSteris CorporationKCT2026-09-24
00724995237158V. MuellerSteris CorporationKCT2026-09-24
00724995237165V. MuellerSteris CorporationKCT2026-09-24
00724995237172V. MuellerSteris CorporationKCT2026-09-24
00724995237189V. MuellerSteris CorporationKCT2026-09-24
00724995237196V. MuellerSteris CorporationKCT2026-09-24
00724995237202V. MuellerSteris CorporationKCT2026-09-24
00724995237219V. MuellerSteris CorporationKCT2026-09-24
00724995237226V. MuellerSteris CorporationKCT2026-09-24
00724995237233V. MuellerSteris CorporationKCT2026-09-24
00724995237240V. MuellerSteris CorporationKCT2026-09-24
00724995237257V. MuellerSteris CorporationKCT2026-09-24
00724995237264V. MuellerSteris CorporationKCT2026-09-24
00724995237271V. MuellerSteris CorporationKCT2026-09-24
00724995237288V. MuellerSteris CorporationKCT2026-09-24
00724995237295V. MuellerSteris CorporationKCT2026-09-24
00724995237301V. MuellerSteris CorporationKCT2026-09-24