FDA.reportPublic FDA data

Vital MIS - Universal Navigation

Primary DI
03662663055819
Brand
Vital MIS - Universal Navigation
Company
ZIMMER BIOMET INC
Model
854M5080
Device description
PASIT STYLUS 80MM
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663055819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663055819036626630558193662663055819

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
045576443
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480511557Lineum®14-52505314-5250532020-07-07
00887868289163Virage® OCT07.01770.00107.01770.0012020-02-13
00887868289170Virage®07.01771.00207.01771.0022020-02-13
00887868289187Virage®07.01772.00207.01772.0022020-02-13
00887868289194Virage®07.01773.00207.01773.0022020-02-13
00887868289385Virage® OCT07.01803.00107.01803.0012020-02-13
00887868244728Vital™730M0011730M00112019-06-04
00887868244735Vital™730M0012730M00122019-06-04
03662663063081Vital Spinal Fixation System710M11562024-06-26
03662663063098Vital Spinal Fixation System710M12562024-06-26
03662663063104Vital Spinal Fixation System710M13562024-06-26
03662663063111Vital Spinal Fixation System710M14562024-06-26
03662663063128Vital Spinal Fixation System710M15562024-06-26
03662663063135Vital Spinal Fixation System710M17562024-06-26
00887868528774VItal Spinal Fixation System850M00302024-06-11
00887868528781VItal Spinal Fixation System850M00312024-06-11
00887868528798VItal Spinal Fixation System850M00322024-06-11
00887868528804VItal Spinal Fixation System850M00332024-06-11
00887868528811VItal Spinal Fixation System850M00342024-06-11
00887868528828VItal Spinal Fixation System850M00352024-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07