FDA.reportPublic FDA data

Vitalitec

Primary DI
04250325499935
Brand
Vitalitec
Company
Vitalitec International Medizintechnik GmbH
Model
VMJ704QR
Catalog number
VMJ704QR
Device description
"QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 4 mm, 7"""
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250325499935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250325499935042503254999354250325499935

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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
04250325499942VitalitecVMJ705QRVMJ705QR2025-05-28
04250325499959VitalitecVMJ901QRVMJ901QR2025-05-28
04250325499966VitalitecVMJ904QRVMJ904QR2025-05-28
04250325499973VitalitecVMJ905QRVMJ905QR2025-05-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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