FDA.report

Spratt mastoid curette

Primary DI
04250381846292
Brand
Spratt mastoid curette
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-405-10
Catalog number
10-405-10
Device description
size 0 17 cm
Published
2022-09-09
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
JYGCURETTE, EAR

Product Code Classifications

CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250381846292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250381846292042503818462924250381846292

GMDN Terms

TermDefinition
Endaural surgical curette, reusableA slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically 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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