FDA.report

Standard Modultainer- 1/2 Size

Primary DI
00817766020575
Brand
Standard Modultainer- 1/2 Size
Company
Tecomet
Model
Mat for 1/2 Size Lower Insert
Catalog number
2-2035
Device description
Mat for 1/2 Size Lower Insert - 3/4" P/N: 98-22035
Published
2016-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817766020575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817766020575008177660205758177660205750817766020575

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical 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 for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118087931
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00817766026522DePuy Synthes2914900122023-04-10
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00817766026546DePuy Synthes2914900142023-04-10
00817766026577DePuy Synthes2914900052023-04-10
00817766026584DePuy Synthes2914900152023-04-10
00817766026591DePuy Synthes2914900032023-04-10
00817766026607DePuy Synthes2914000132023-04-10
00817766026249Smith & Nephew Tray - Offset Cup Impactor Lid33000206-35122020-05-14
00817766026348Smith & Nephew Tray - Offset Cup Impactor Base33000306-35132020-05-14
00817766024436KARL STORZKSE06010KSE060102019-12-12
00817766024863KARL STORZ04-1268-US04-1268-US2019-12-12
00817766024870KARL STORZ05-327505-32752019-12-12
00817766024887KARL STORZKSE09007KSE090072019-12-12
00817766024900KARL STORZKSE09006KSE090062019-12-12

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