FDA.reportPublic FDA data

Antrum trocar, oblique beak

Primary DI
04250381812877
Brand
Antrum trocar, oblique beak
Company
Spiggle & Theis Medizintechnik GmbH
Model
30-156-50
Catalog number
30-156-50
Device description
5.0x4.0 mm, for 4 mm endoscopes
Published
2025-09-10
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
KTETROCAR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381812877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381812877042503818128774250381812877

GMDN Terms#

Term, Definition table
TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. 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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04250381812846Antrum trocar, beakedSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812853Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
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