FDA.report

Stille-Luer Bone Rongeur

Primary DI
00840199517671
Brand
Stille-Luer Bone Rongeur
Company
KOROS U.S.A., INC.
Model
7352-65
Catalog number
7352-65
Device description
Stille-Luer Bone Rongeur 6mm, 23cm Long
Published
2021-10-01
Public version status
New
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
00840199517671Direct MarkingGS10
10840199517678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199517671008401995176718401995176710840199517671
1084019951767810840199517678

GMDN Terms

TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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