FDA.reportPublic FDA data

SCANLAN® MicroSurgical Instruments

Primary DI
00846159010916
Brand
SCANLAN® MicroSurgical Instruments
Company
SCANLAN INTERNATIONAL INC
Model
8008-236
Catalog number
8008-236
Device description
"Phlebectomy Hook, Angled right, 5 1/2"" / 14 cm"
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159010916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159010916008461590109168461590109160846159010916

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
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
00846159039931SCANLAN® ScissorsQ2423-7Q2423-72026-05-28
00846159039948SCANLAN® ScissorsQ2428-7Q2428-72026-05-28
00846159039955SCANLAN® ScissorsQ2429-7Q2429-72026-05-28
00846159039962SCANLAN® ScissorsQ2430-7Q2430-72026-05-28
00846159039979SCANLAN® ScissorsQ247-7Q247-72026-05-28
00846159039986SCANLAN® ScissorsQ25010-7Q25010-72026-05-28
00846159039993SCANLAN® ScissorsQ26044-7Q26044-72026-05-28
00846159040005SCANLAN® ScissorsQ27010-7Q27010-72026-05-28
00846159040012SCANLAN® ScissorsQ27065-7Q27065-72026-05-28
00846159040029SCANLAN® ScissorsQ27079-7NQ27079-7N2026-05-28
00846159040036SCANLAN® ScissorsQ27082-7NQ27082-7N2026-05-28
00846159040043SCANLAN® ScissorsQ27119-7Q27119-72026-05-28
00846159040050SCANLAN® ScissorsQ28032-7Q28032-72026-05-28
00846159040067SCANLAN® ScissorsQ28080-7Q28080-72026-05-28
00846159040074SCANLAN® ScissorsQ28097-7Q28097-72026-05-28
00846159040081SCANLAN® ScissorsQ28119-9Q28119-92026-05-28
00846159040098SCANLAN® ScissorsQ29092-9Q29092-92026-05-28
00846159040104SCANLAN® ScissorsQ32034-7NQ32034-7N2026-05-28
00846159040111SCANLAN® ScissorsQ32035-7NQ32035-7N2026-05-28
00846159040128SCANLAN® ScissorsQ33032-7NQ33032-7N2026-05-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
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