FDA.reportPublic FDA data

Vitalitec

Primary DI
04250325436312
Brand
Vitalitec
Company
Vitalitec International Medizintechnik GmbH
Model
L-IT05
Catalog number
L-IT05
Device description
Insulated Tube 5 mm
Published
2017-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944270000CIT MONOPOLAR LAPAROSCOPIC INSTRMENTSChirurgische Instrumente1995-07-25HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250325436312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250325436312042503254363124250325436312

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328485453
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250325498877VitalitecVK.J805CVUQRVK.J805CVUQR2025-05-28
04250325499423VitalitecVMJ902QRVMJ902QR2025-05-28
04250325499430VitalitecVMJ903QRVMJ903QR2025-05-28
04250325499720VitalitecVK.J704CVUQRVK.J704CVUQR2025-05-28
04250325499737VitalitecVK.J705CVUQRVK.J705CVUQR2025-05-28
04250325499744VitalitecVK.J801CVUQRVK.J801CVUQR2025-05-28
04250325499751VitalitecVMJ1001QRSVMJ1001QRS2025-05-28
04250325499768VitalitecVMJ1002QRSVMJ1002QRS2025-05-28
04250325499775VitalitecVMJ1003QRSVMJ1003QRS2025-05-28
04250325499782VitalitecVMJ1004QRSVMJ1004QRS2025-05-28
04250325499799VitalitecVMJ1005QRSVMJ1005QRS2025-05-28
04250325499805VitalitecVMJ1005QRVMJ1005QR2025-05-28
04250325499812VitalitecVMJ1002QRBCVMJ1002QRBC2025-05-28
04250325499904VitalitecVMJ701QRVMJ701QR2025-05-28
04250325499911VitalitecVMJ702QRVMJ702QR2025-05-28
04250325499928VitalitecVMJ703QRVMJ703QR2025-05-28
04250325499935VitalitecVMJ704QRVMJ704QR2025-05-28
04250325499942VitalitecVMJ705QRVMJ705QR2025-05-28
04250325499959VitalitecVMJ901QRVMJ901QR2025-05-28
04250325499966VitalitecVMJ904QRVMJ904QR2025-05-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
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