FDA.reportPublic FDA data

Sluder-Ballenger tonsillotome blade

Primary DI
04250676733962
Brand
Sluder-Ballenger tonsillotome blade
Company
Spiggle & Theis Medizintechnik GmbH
Model
40-350-01
Catalog number
40-350-01
Device description
simal type, size 1
Published
2025-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676733962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676733962042506767339624250676733962

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil knifeA hand-held manual surgical instrument intended for the removal of the tonsils during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, scythe-like, cutting blade at the distal end (the internal radius of the curve has the cutting edge) which is normally quite small; it has a very long and slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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