FDA.report

Tools - HCS

Primary DI
00842188111464
Brand
Tools - HCS
Company
TRIMED, INCORPORATED
Model
CSCADDY-2.3
Catalog number
CSCADDY-2.3
Device description
Compression Screw Caddy - 2.3
Published
2016-09-07
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

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842188111464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188111464008421881114648421881114640842188111464

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags

DUNS number
138041277
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00842188127663Foot PlatesEOP-4SEOP-4S2024-04-24
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00842188127687Foot PlatesHP-4LHP-4L2024-04-24
00842188127694Foot PlatesHP-4SHP-4S2024-04-24
00842188127700Foot PlatesTN-7TN-72024-04-24
00842188127717Foot PlatesTN-7LTN-7L2024-04-24
00842188127724Foot PlatesTN-7STN-7S2024-04-24
00842188127731Foot PlatesMCFL-12MCFL-122024-04-24
00842188127748Foot PlatesMCFL-12LMCFL-12L2024-04-24
00842188127755Foot PlatesMCFR-12MCFR-122024-04-24
00842188127762Foot PlatesMCFR-12LMCFR-12L2024-04-24
00842188127779Foot PlatesMCFL-17MCFL-172024-04-24
00842188127786Foot PlatesMCFL-17LMCFL-17L2024-04-24
00842188127793Foot PlatesMCFR-17MCFR-172024-04-24
00842188127809Foot PlatesMCFR-17LMCFR-17L2024-04-24
00842188127915Foot PlatesMOPL-4LMOPL-4L2024-04-24

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