FDA.reportPublic FDA data

Vitalitec

Primary DI
04250325437463
Brand
Vitalitec
Company
Vitalitec International Medizintechnik GmbH
Model
L-PHS
Catalog number
L-PHS
Device description
Composite handle HF connection, without ratchet
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
04250325437463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250325437463042503254374634250325437463

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
04255968301768VitalitecVK.J806QRS40DVK.J806QRS40D2026-09-30
04255968301881VitalitecVK.J806QRS90VK.J806QRS902026-09-30
04255968302000VitalitecVK.J806QRS90DVK.J806QRS90D2026-09-30
04255968302208VitalitecVK.J806QRBCVK.J806QRBC2026-09-30
04255968302284VitalitecVK.J806CT90DVK.J806CT90D2026-09-30
04255968302352VitalitecVK.J806CVUQRVK.J806CVUQR2026-09-30
04255968302420VitalitecVK.J806QR40DVK.J806QR40D2026-09-30
04255968302499VitalitecVK.J806QR90DVK.J806QR90D2026-09-30
04255968302567VitalitecVK.J9015CT90VK.J9015CT902026-09-30
04255968302574VitalitecVK.J9015QR90VK.J9015QR902026-09-30
04250325493537VitalitecVK.J804CT90VK.J804CT902026-09-22
04255968301713VitalitecVK.J801QRS40DVK.J801QRS40D2026-09-22
04255968301720VitalitecVK.J802QRS40DVK.J802QRS40D2026-09-22
04255968301737VitalitecVK.J803QRS40DVK.J803QRS40D2026-09-22
04255968301744VitalitecVK.J804QRS40DVK.J804QRS40D2026-09-22
04255968301751VitalitecVK.J805QRS40DVK.J805QRS40D2026-09-22
04255968301836VitalitecVK.J801QRS90VK.J801QRS902026-09-22
04255968301843VitalitecVK.J802QRS90VK.J802QRS902026-09-22
04255968301850VitalitecVK.J803QRS90VK.J803QRS902026-09-22
04255968301867VitalitecVK.J804QRS90VK.J804QRS902026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029178EndoplusEndoplusHET2026-07-08
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
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
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29