FDA.reportPublic FDA data

BrainLab NaviVision Sleeve Guide

Primary DI
00841823100733
Brand
BrainLab NaviVision Sleeve Guide
Company
Ad-Tech Medical Instrument Corporation
Model
BLNG-2X
Catalog number
BLNG-2X
Published
2023-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841823100733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823100733008418231007338418231007330841823100733

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags#

DUNS number
174813410
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841823108814Anchor Bolt Kit, LSB StyleLSBK1-AX-05LSBK1-AX-052026-04-08
00841823108821Anchor Bolt Kit, LSB StyleLSBK1-BX-05LSBK1-BX-052023-08-28
00841823108838Anchor Bolt Kit, LSB StyleLSBK1-CX-04LSBK1-CX-042023-08-28
00841823108845Anchor Bolt Kit, LSB StyleLSBK1-CX-05LSBK1-CX-052023-08-28
00841823108852Anchor Bolt Kit, LSB StyleLSBK2-AX-04LSBK2-AX-042023-08-28
00841823108869Anchor Bolt Kit, LSB StyleLSBK2-BX-04LSBK2-BX-042023-08-28
00841823109521Anchor Bolt Kit, LSB StyleLSBK1-CX-06LSBK1-CX-062023-08-28
00841823109538Anchor Bolt Kit, LSB StyleLSBK1-BX-06LSBK1-BX-062023-08-28
00841823109545Anchor Bolt Kit, LSB StyleLSBK1-AX-06LSBK1-AX-062023-08-28
00841823101228Subdural ElectrodeDG20A-SP07X-UPBDG20A-SP07X-UPB2016-09-23
00841823101235Subdural ElectrodeDG20A-SP10X-G00DG20A-SP10X-G002016-09-23
00841823101242Subdural ElectrodeDG20A-SP10X-GE2DG20A-SP10X-GE22016-09-23
00841823101259Subdural ElectrodeDG20A-SP10X-T00DG20A-SP10X-T002016-09-23
00841823101266Subdural ElectrodeDG20A-SP10X-U00DG20A-SP10X-U002016-09-23
00841823101273Subdural ElectrodeDG20A-SP10X-UE2DG20A-SP10X-UE22016-09-23
00841823101280Subdural ElectrodeDG24A-SP10X-000DG24A-SP10X-0002016-09-23
00841823101297Subdural ElectrodeDG24A-SP10X-G00DG24A-SP10X-G002016-09-23
00841823101303Subdural ElectrodeDG32A-SP10X-U00DG32A-SP10X-U002016-09-23
00841823101310Subdural ElectrodeDG32A-SP10X-V00DG32A-SP10X-V002016-09-23
00841823101327Subdural ElectrodeDG48B-SP10X-G00DG48B-SP10X-G002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436040Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436057Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436064Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436071Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436088Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436095Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436101Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17