FDA.report

STILLE Bone Rongeurs

Primary DI
07332339204013
Brand
STILLE Bone Rongeurs
Company
Stille AB
Model
105-17265
Catalog number
105-17265
Device description
BONE RONGEUR ORIGINAL LEKSELL-STILLE curved wide jaws 24 cm 9.5 in
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
07332339204013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332339204013073323392040137332339204013

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.

Device Sizes

TypeValueUnit
Length24Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+46730333841pontus.luning@stille.se

Regulatory Flags

DUNS number
355280827
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
true
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

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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
07332339238230STILLE Titanium Micro Needle Holders117-C106-15-TI117-C106-15-TI2023-12-06
07332339231910STILLE Scissors100-101-1082100-101-10822023-10-04
07332339237530imagiQ507-30236-1507-30236-12022-11-23
07332339237387STILLE Scissors100-101-1087100-101-10872022-09-13
07332339101848STILLE Scissors100-101-1029100-101-10292022-07-27
07332339102708STILLE Scissors100-101-1047100-101-10472022-04-20
07332339221577ReisonLateral Support, wide without clamp514-1003652022-04-04
07332339221584ReisonCushion for armboard, concave514-1003822022-04-04

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