FDA.report

SCANLAN® Dennis Rib Cutter

Primary DI
00846159033694
Brand
SCANLAN® Dennis Rib Cutter
Company
SCANLAN INTERNATIONAL INC
Model
9909-902
Catalog number
9909-902
Device description
SCANLAN® Dennis Rib Cutter 15mm Cut Height
Published
2018-07-24
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
00846159033694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159033694008461590336948461590336940846159033694

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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

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00846159036114SCANLAN® Minimally Invasive Instrument9009-2199009-2192025-09-18
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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
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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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