FDA.reportPublic FDA data

MICTEC PLEURAELEVATORIUM ELEVATOR

Primary DI
00192896008755
Brand
MICTEC PLEURAELEVATORIUM ELEVATOR
Company
SONTEC INSTRUMENTS, INC.
Model
20942-03
Device description
MICTEC PLEURAELEVATORIUM CURVED RIGHT
Published
2018-08-24
Public version status
New
Distribution status
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
B09920942030PreviousHIBCC0
00192896008755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896008755001928960087551928960087550192896008755

GMDN Terms#

Term, Definition table
TermDefinition
Lung spatulaA hand-held manual surgical instrument designed to manipulate the pulmonary tissue/surfaces of the lungs during a surgical intervention in the thorax. It typically consists of a large flat blunt blade (no sharp edges) at the distal end and a strong handle at the proximal end. It is usually made of stainless steel and is available with a variety of blade designs, e.g., curved and flat with a protected rounded end, a wire basket structure of interconnected round wires, or broad and flat with fenestrations. The blade and handle can be designed to be at various ergonomic angles to each other. This instrument is sometimes referred to as a lung retractor. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length300Millimeter

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam 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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00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
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00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
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00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

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Primary DI, Brand, Company table
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