FDA.report

CalTray

Primary DI
G346P1400
Brand
CalTray
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
P140
Device description
Plastic Instrument Tray: 6 x 10 x 2.0" (Base, Lid, and Finger Mat.)
Published
2023-01-04
Public version status
New
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
FSMTray, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G346P1400PrimaryHIBCC0

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

Contacts

PhoneEmail
(909) 984-4614epsilonusa1@gmail.com

Regulatory Flags

DUNS number
917922762
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

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G346EP19A0Epsilon USAEP-19A2026-03-24
G346EA0323SS0Epsilon USAEA-03-23 SS2026-03-12
G346EEC2000Epsilon USAEEC-2002026-03-04
G346BP01RSS0Epsilon USABP-01R SS2026-03-02
G34EP223R0Epsilon USAEP-223R2026-02-27
G346ET160Epsilon USAET-162026-02-17
G3446EP219SS0Epsilon USAEP-219SS2026-02-16
G346ET390Epsilon USAET-392026-01-21
G346EL180Epsilon USAEL-182026-01-19
G346EEN0132Epsilon USAEEN-013-22025-12-17
G346ERF12C0Epsilon USAERF-12C2025-11-24
G346ESF03SS0Epsilon USAESF-03SS2025-11-13
G346EP55L0Epsilon USAEP-55L2025-09-26
G346EP1650Epsilon USAEP-1652025-09-23
G346EC222SS0Epsilon USAEC-222 SS2025-09-18
G346EP98SS0Epsilon USAEP-98SS2025-09-03
G34EP223L0Epsilon USAEP-223L2025-08-13
G346EA01L212521GSS0Epsilon USAEA-01L25-21GSS2025-08-08
G346EC208Epsilon USAEC-2082025-07-07
G346ECF54SS0Epsilon USAECF-54SS2025-07-07

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