FDA.reportPublic FDA data

Biover

Primary DI
07640174510375
Brand
Biover
Company
Biover AG
Model
MI8012
Catalog number
MI8012
Device description
Titanium micro needle holder, 150mm length, 0.4mm tip, curved, 8mm grip
Published
2023-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640174510375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640174510375076401745103757640174510375

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter
Outer Diameter0.4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
482102712
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
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
07640174510245BioverTKLV-1TKLV-12016-09-27
07640174510412GEM BIOVER MICROINSTRUMENTMI8040.1MI8040.12024-10-30
07640174510351BioverMI8038MI80382023-02-28
07640174510368BioverMI8039MI80392023-02-28
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
00190776411107MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411473MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411497MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411510MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407513MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407315MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776407360MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
00190776404222MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17