FDA.reportPublic FDA data

Vitalitec

Primary DI
04255968301010
Brand
Vitalitec
Company
Vitalitec International Medizintechnik GmbH
Model
VK.J1301CTBC
Catalog number
VK.J1301CTBC
Device description
QUICK RELEASE Micro Kerrison Rongeur thin footplate, 12 mm bite opening, 40d UP, 1 mm, 13", bayoneted
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
04255968301010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04255968301010042559683010104255968301010

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.

Regulatory Flags#

DUNS number
328485453
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250325495029VitalitecVK.J1301QRVK.J1301QR2026-08-27
04250325495036VitalitecVK.J1302QRVK.J1302QR2026-08-27
04250325495050VitalitecVK.J1304QRVK.J1304QR2026-08-27
04255968300884VitalitecVK.J1105QRBC90VK.J1105QRBC902026-08-27
04255968300891VitalitecVK.J1106QRBC90VK.J1106QRBC902026-08-27
04255968300914VitalitecVK.J1106QRVK.J1106QR2026-08-27
04255968300921VitalitecVK.J1104QRBCVK.J1104QRBC2026-08-27
04255968300938VitalitecVK.J1105QRBCVK.J1105QRBC2026-08-27
04255968300945VitalitecVK.J1106QRBCVK.J1106QRBC2026-08-27
04255968300952VitalitecVK.J1201CTBCVK.J1201CTBC2026-08-27
04255968300969VitalitecVK.J1202CTBCVK.J1202CTBC2026-08-27
04255968300976VitalitecVK.J1203CTBCVK.J1203CTBC2026-08-27
04255968300983VitalitecVK.J1204CTBCVK.J1204CTBC2026-08-27
04255968300990VitalitecVK.J1205CTBCVK.J1205CTBC2026-08-27
04255968301003VitalitecVK.J1206CTBCVK.J1206CTBC2026-08-27
04255968301027VitalitecVK.J1302CTBCVK.J1302CTBC2026-08-27
04255968301034VitalitecVK.J1303CTBCVK.J1303CTBC2026-08-27
04255968301041VitalitecVK.J1304CTBCVK.J1304CTBC2026-08-27
04255968301058VitalitecVK.J1305CTBCVK.J1305CTBC2026-08-27
04255968301065VitalitecVK.J1306CTBCVK.J1306CTBC2026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424008MillenniumAvalign Technologies, Inc.HAE2026-08-27
00190776424084MillenniumAvalign Technologies, Inc.HAE2026-08-27
00850003512006SteribiteSteribite, LLCHAE2026-08-27
00850003512044SteribiteSteribite, LLCHAE2026-08-27
00850003512082SteribiteSteribite, LLCHAE2026-08-27
00850003512129SteribiteSteribite, LLCHAE2026-08-27
00850003512167SteribiteSteribite, LLCHAE2026-08-27
00850003512235SteribiteSteribite, LLCHAE2026-08-27
00850003512273SteribiteSteribite, LLCHAE2026-08-27
00850003512310SteribiteSteribite, LLCHAE2026-08-27
00850003512358SteribiteSteribite, LLCHAE2026-08-27
04250325495029VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495036VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495050VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300884VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300891VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300914VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300921VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300938VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300945VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300952VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300969VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300976VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300983VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300990VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301003VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301027VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301034VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301041VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301058VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27