FDA.reportPublic FDA data

MICTEC VESSEL SPATULA

Primary DI
B09920942160
Brand
MICTEC VESSEL SPATULA
Company
SONTEC INSTRUMENTS, INC.
Model
20942-16
Device description
MICTEC VESSEL SPATULA
Published
2016-09-30
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
B09920942160PreviousHIBCC0
00192896008786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896008786001928960087861928960087860192896008786

GMDN Terms#

Term, Definition table
TermDefinition
Vascular spatulaA hand-held surgical instrument designed to be used within the vasculature (a blood vessel) to scrape, manipulate, and remove tissue therein. It typically made of high-grade stainless steel and consists of a flat blunt blade (no sharp edges) that is either single-ended or double-ended (a blade at either end). It is available with a variety of blade designs, e.g., curved and spoon-shaped or curved and straight. The handle can be placed proximally or be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Millimeter

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

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

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00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24
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00192896123540Green Retractor207-298207-2982026-06-24
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
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00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
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