FDA.report

SOLID FLAT TRAY COVER

Primary DI
00192896070646
Brand
SOLID FLAT TRAY COVER
Company
SONTEC INSTRUMENTS, INC.
Model
ST10-02-2
Catalog number
ST10-02-2
Device description
SOLID FLAT TRAY COVER RECESSED STRAP HANDLES
Published
2018-09-11
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
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896070646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896070646001928960706461928960706460192896070646

GMDN Terms

TermDefinition
General-purpose bowl, reusableA bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary from round, oblong, deep or quite shallow. This is a reusable device.

Device Sizes

TypeValueUnit
Length10Inch
Width6.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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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