FDA.reportPublic FDA data

Suction dissector

Primary DI
04250676734792
Brand
Suction dissector
Company
Spiggle & Theis Medizintechnik GmbH
Model
30-1858
Catalog number
30-1858
Device description
upcurved right, blunt 13 cm, Luer-Lock
Published
2022-09-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZFTUBE, EAR SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676734792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676734792042506767347924250676734792

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050659354647Brünings anastignatic aural magnifier10-180-0010-180-002026-01-21
04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04250676747211Tray set with flex band1000617-31000617-32025-12-03
04250676747235Filter modul with 8 x LM10-845-0110-845-012025-12-03
04250676747228Tray set1000617-3-01000617-3-02025-12-03
04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03
04251993601927Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04251993601934Tray set with flex band1000617-31000617-32025-12-03
04250381821503Gillies skin hook6-1240/186-1240/182025-09-29
04250676710017Hook85-900-0185-900-012025-09-29
04250676711625ForkAHA-0147AHA-01472025-09-29
04250676716880ENT-single-use suction tubes, angled301302030130202025-09-29
04250676716897ENT-single-use suction tubes, angled301303030130302025-09-29
04250676731982Salivary duct probe40-611-0040-611-002025-09-29
04250676731999Salivary duct probe40-611-0140-611-012025-09-29
04250676732002Salivary duct probe40-611-0240-611-022025-09-29
04250676732026Salivary duct probe40-611-0440-611-042025-09-29
04250676732033Salivary duct probe40-611-0540-611-052025-09-29
04250676740625Bowman salivary duct probe40-609-4040-609-402025-09-29
04250676740632Bowman salivary duct probe40-609-0040-609-002025-09-29

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Primary DI, Brand, Company table
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00757770436842Bausch + LombBausch & Lomb IncorporatedJZF2025-11-14
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00757770452682Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
00757770680498Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
04250676740533Saxby-IrrigatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-11
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04250676722560Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722577Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
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04250676722607Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
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04250676733153Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
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04250676733191Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733207Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
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04250676742865Preyer dissector, sinus tympaniSpiggle & Theis Medizintechnik GmbHJZF2025-09-03