FDA.reportPublic FDA data

STILLE Various Instruments

Primary DI
07332339208301
Brand
STILLE Various Instruments
Company
Stille AB
Model
125-19170
Catalog number
125-19170
Device description
GUIDE/DURA PROTECTOR for Wire Saws STILLE-GIGLI 34 cm 13 in
Published
2020-09-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332339208301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332339208301073323392083017332339208301

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw, flexibleA hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length34Centimeter

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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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Primary DI, Brand, Company table
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04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08