FDA.reportPublic FDA data

Vitalitec Clip Removers

Primary DI
00857987006194
Brand
Vitalitec Clip Removers
Company
VITALITEC INTERNATIONAL, INC.
Model
CR428-E
Device description
Reusable Clip Removers CR428-E (28cm SLS Clip Remover)
Published
2018-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HBQInstrument, Clip Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBQInstrument, Clip RemovalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857987006194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857987006194008579870061948579870061940857987006194

GMDN Terms#

Term, Definition table
TermDefinition
Surgical clip remover, reusableA scissors- or tweezers-like surgical instrument with two blades joined at their proximal end or midpoint intended to be used to for grasping, opening, and removing a tissue clip. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
508.747.6033lylehoward@aol.com

Regulatory Flags#

DUNS number
121464288
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044817016CYGNET Sterilization Tray VTI1020520-012023-05-01
00857987006255Vitalitec Shovel RetractorsV90952018-12-11
00850001784580Vitalitec MI Ball Point ProbeMI-70862018-12-13
00850001784528Vitalitec Surgical ScissorsMI-30332018-12-13
00850001784566Vitalitec Surgical ScissorsMI-35332018-12-13
00850001784573Vitalitec Surgical ScissorsMI-35612018-12-13
00850001784948AY Cygnet Clampvsay00064vsay000642022-08-17
00852621004697MICA AppliersPLM535-1PLM535-12022-08-17
00850001784917Vitalitec Clip AppliersPBC228PBC2282022-08-16
00850001784924Vitalitec Clip AppliersPVC328PVC3282022-08-16
00850001784931Vitalitec Clip AppliersPOC428POC4282022-08-16
00850001784955AY Cygnet ClampVSAY-LK66VSAY-LK662022-08-16
00850001784962AY Cygnet ClampVSAY-LK86VSAY-LK862022-08-16
00850001784979MICA AppliersPWM635-1PWM635-12022-08-16
00850001784986MICA AppliersPRM135-1PRM135-12022-08-16
00850001784993MICA AppliersPJM135-1PJM135-12022-08-16
00850044817009MICA AppliersPBM235-1PBM235-12022-08-16
00850001784689Vitalitec Clip AppliersPWT620PWT6202022-08-10
00850001784696Vitalitec Clip AppliersPJT120PJT1202022-08-10
00850001784702Vitalitec Clip AppliersPRT120PRT1202022-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653170036AESCULAPAesculap AGHBQ2020-08-10
00840096207583Khaimi Concentrator, Smooth, 0.45KATALYST SURGICAL LLCHBQ2020-06-08
04038653170005AESCULAPAesculap AGHBQ2020-04-22
04038653170012AESCULAPAesculap AGHBQ2020-04-22
04038653170029AESCULAPAesculap AGHBQ2020-04-22
00840096203660Khaimi Concentrator, 0.25 mLKATALYST SURGICAL LLCHBQ2019-07-02
00840096203684Khaimi Concentrator, 0.33 mLKATALYST SURGICAL LLCHBQ2019-07-02
00840096203691Khaimi Concentrator, 0.35 mLKATALYST SURGICAL LLCHBQ2019-07-02
00857987006187Vitalitec Clip RemoversVITALITEC INTERNATIONAL, INC.HBQ2018-12-13
24026704508758PILLINGTELEFLEX INCORPORATEDHBQ2018-09-15
10884521057616Lapro-ClipCovidien LPHBQ2018-08-10
00810607000453Clip Remover ACRA-CUT INCHBQ2017-05-01