FDA.report

SCANLAN® Rongeur

Primary DI
00846159027563
Brand
SCANLAN® Rongeur
Company
SCANLAN INTERNATIONAL INC
Model
7511-04
Catalog number
7511-04
Device description
Kerrison Rongeur
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTXRongeur

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159027563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159027563008461590275638461590275630846159027563

GMDN Terms

TermDefinition
Rib rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed to cut and shorten rib bones, and round the rib stumps, during a surgical intervention. It is typically made of metal with a forceps- or pliers-like design, is and designed to withstand the forces required to bite over tough/hard tissue. It is not intended for endoscopic access. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00846159035926SCANLAN® Forceps4004-1574004-1572025-11-13
00846159036190SCANLAN® Minimally Invasive Instrument9009-917K9009-917K2025-11-13
00846159036114SCANLAN® Minimally Invasive Instrument9009-2199009-2192025-09-18
00846159036138SCANLAN® Minimally Invasive Instrument9209-2889209-2882025-09-18
00846159036398SCANALN® Needle Holder6006-56-3N6006-56-3N2025-06-09
00846159011944SCANLAN® Titanium Neuro Forceps3003-154-33003-154-32025-05-29
00846159012002SCANLAN® Titanium Neuro Forceps3003-158-33003-158-32025-05-29
00846159012040SCANLAN® Titanium Neuro Forceps3003-159-33003-159-32025-05-29
00846159012767Scanlan Titanium Bayonet Forceps3003-8403003-8402025-05-29
00846159012798SCANLAN® Titanium Forceps3003-843N3003-843N2025-05-29
00846159013733SCANLAN® Forceps4004-97-3A4004-97-3A2025-05-29
00846159014907SCANLAN® Instruments9009-3609009-3602025-05-29
00846159033229SCANLAN® Neuro Instruments3003-8413003-8412025-05-29
00846159036350SCANLAN® 7007-256-5SC2 7007-256-5SC22025-05-08
00846159036367SCANLAN®7007-252-5SC27007-252-5SC22025-05-08
00846159012576SCANLAN® Titanium Forceps3003-904N3003-904N2025-01-31
00846159012774SCANLAN® Neuro Instruments3003-841N3003-841N2025-01-31
00846159023053SCANLAN® Minimally Invasive Instrumentation9009-360N-12C9009-360N-12C2025-01-31
00846159036251SCANLAN® Titanium Neuro Forceps3003-154-3N3003-154-3N2025-01-31
00846159036268SCANLAN® Titanium Neuro Forceps3003-158-3N3003-158-3N2025-01-31

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