FDA.report

Cottle chisel

Primary DI
04250676740540
Brand
Cottle chisel
Company
Spiggle & Theis Medizintechnik GmbH
Model
20-405-03
Catalog number
20-405-03
Device description
flat 3 mm, 18.5 cm
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KANCHISEL, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KANChisel, NasalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250676740540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250676740540042506767405404250676740540

GMDN Terms

TermDefinition
Nasal chiselA single-bladed, surgical instrument, bevelled on one side that is used to cut and shape the nasal bones during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags

DUNS number
332893028
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
true
Sterilization required before use
true

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