FDA.report

Tools - AFS

Primary DI
00842188126901
Brand
Tools - AFS
Company
TRIMED, INCORPORATED
Model
AFS-SCREW-LID
Catalog number
AFS-SCREW-LID
Device description
AFS Screw Caddy Lid
Published
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842188126901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188126901008421881269018421881269010842188126901

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
false
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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00842188127670Foot PlatesHP-4HP-42024-04-24
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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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