FDA.reportPublic FDA data

MICTEC TALKUM SPRAY GLASS BOTTLE

Primary DI
B0990411020030
Brand
MICTEC TALKUM SPRAY GLASS BOTTLE
Company
SONTEC INSTRUMENTS, INC.
Model
04-11020-03
Catalog number
04-11020-03
Device description
MICTEC TALKUM SPRAY GLASS BOTTLE
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002877000MICTEC ENDOSCOPES AND ACCESSORIESDufner Instrumente GmbH2001-02-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0990411020030PreviousHIBCC0
00192896000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896000087001928960000871928960000870192896000087

GMDN Terms#

Term, Definition table
TermDefinition
Sterile solution storage bottle, reusableAn empty glass or plastic container, typically with a relatively narrow neck and capable of being sterilized, intended for the safe storage and easy handling of sterile solutions (e.g., sterile distilled water or saline) that are used during intravenous and/or irrigation procedures. It is produced in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
8008217496INFO@SONTECINSTRUMENTS.COM

Regulatory Flags#

DUNS number
040729840
Device count
1
Lot or batch
true
Sterilization required before use
true

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