FDA.report

STILLE Gouges

Primary DI
07332339206642
Brand
STILLE Gouges
Company
Stille AB
Model
111-21335-10
Catalog number
111-21335-10
Device description
GOUGE ORIGINAL STILLE 10 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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDHGouge, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332339206642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332339206642073323392066427332339206642

GMDN Terms

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

TypeValueUnit
Length21Centimeter

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

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07332339242237imagiQPan Handle555-17602024-12-11
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07332339242459imagiQControl module555-17652024-12-11
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04026575033553Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
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