FDA.report

STILLE Various Instruments

Primary DI
07332339211318
Brand
STILLE Various Instruments
Company
Stille AB
Model
119-30022
Catalog number
119-30022
Device description
CASTROVIEJO STILLE CALIPER 0-20 mm 8 cm 3.1 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

Related Records

Contact Domains

Product Codes

CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332339211318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332339211318073323392113187332339211318

GMDN Terms

TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). This is a reusable device.

Device Sizes

TypeValueUnit
Length8Centimeter

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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