FDA.reportPublic FDA data

STILLE Gouges

Primary DI
07332339206659
Brand
STILLE Gouges
Company
Stille AB
Model
111-21335-12
Catalog number
111-21335-12
Device description
GOUGE ORIGINAL STILLE 12 mm 21 cm 8.25 in
Published
2020-09-28
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
GDHGouge, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332339206659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332339206659073323392066597332339206659

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length21Centimeter

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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