FDA.reportPublic FDA data

STILLE Bone Rongeurs

Primary DI
07332339203948
Brand
STILLE Bone Rongeurs
Company
Stille AB
Model
105-17216
Catalog number
105-17216
Device description
BONE RONGEUR STILLE curved 15 cm 6 in
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332339203948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332339203948073323392039487332339203948

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+46730333841pontus.luning@stille.se

Regulatory Flags#

DUNS number
355280827
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332339220587imagiQSide rail535-17202020-09-24
07332339220617imagiQSide rail535-17242020-09-24
07332339220655imagiQSide rail535-17282020-09-24
07332339220662imagiQFistula arm board535-17302020-09-24
07332339229559imagiQSide rail535-17232020-09-24
07332339232542MedstoneCatheter tray505-11312020-09-24
07332339221614ReisonLeg rest excluding clamp (1 pair)514-1004502022-04-04
07332339220594imagiQSide rail535-17212025-01-27
07332339220624imagiQSide rail535-17252025-01-27
07332339229566imagiQSide rail535-17292025-01-27
07332339242237imagiQPan Handle555-17602024-12-11
07332339242428imagiQPan Handle555-17612024-12-11
07332339242435imagiQCatheter tray 1000mm555-17502024-12-11
07332339242442imagiQCatheter tray 500mm555-17512024-12-11
07332339242459imagiQControl module555-17652024-12-11
07332339242466imagiQControl module555-17662024-12-11
07332339238179imagiQimagiQ3 Legacy550-17002024-11-04
07332339242473imagiQimagiQ3 Legacy550-17022024-11-04
07332339242480imagiQimagiQ3 Legacy550-17032024-11-04
07332339211769STILLE Various Instruments119-30010-15119-30010-152020-09-30

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Primary DI, Brand, Company table
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G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
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07640178988767JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
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07640185340824SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
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