FDA.reportPublic FDA data

Biover

Primary DI
07640174510245
Brand
Biover
Company
Biover AG
Model
TKLV-1
Catalog number
TKLV-1
Device description
Disposable Microvascular Clamps, Veins, single, Ø 2 mm
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011208000BIOVERBiover AG2002-10-02DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640174510252PackageGS110Not in Commercial Distribution
7640174510252PackageGS110In Commercial Distribution
07640174510245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640174510252076401745102527640174510252
07640174510245076401745102457640174510245

GMDN Terms#

Term, Definition table
TermDefinition
Vascular clamp, single-useA sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length21.5Millimeter
Width3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature16 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41416300022biover@biover.ch

Regulatory Flags#

DUNS number
482102712
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640174510023BioverTKS-2TKS-22016-09-27
07640174510047BioverTKM-1TKM-12016-09-27
07640174510160BioverTKSV-1TKSV-12016-09-27
07640174510207BioverTKMV-1TKMV-12016-09-27
07640174510269BioverTKLV-2TKLV-22016-09-27
07640174510009BioverTKS-1TKS-12016-09-27
07640174510061BioverTKM-2TKM-22016-09-27
07640174510085BioverTKL-1TKL-12016-09-27
07640174510108BioverTKL-2TKL-22016-09-27
07640174510122BioverTKFV-1TKFV-12016-09-27
07640174510146BioverTKFV-2TKFV-22016-09-27
07640174510184BioverTKSV-2TKSV-22016-09-27
07640174510221BioverTKMV-2TKMV-22016-09-27
07640174510412GEM BIOVER MICROINSTRUMENTMI8040.1MI8040.12024-10-30
07640174510351BioverMI8038MI80382023-02-28
07640174510368BioverMI8039MI80392023-02-28
07640174510375BioverMI8012MI80122023-02-28
07640174510382BioverMI8013MI80132023-02-28
07640174510399BioverMI8038.1MI8038.12023-02-28
07640174510405BioverMI8012.2MI8012.22023-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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10381780143055Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143062Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143079Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143086Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780143093Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14