Inflation device 2080-9030040-US

GUDID 04250676743473

Spiggle & Theis Medizintechnik GmbH

Catheter/overtube balloon inflator, single-use
Primary Device ID04250676743473
NIH Device Record Key810d4d40-92c0-45b6-acea-398b212d141e
Commercial Distribution StatusIn Commercial Distribution
Brand NameInflation device
Version Model Number2080-9030040-US
Catalog Number2080-9030040-US
Company DUNS332893028
Company NameSpiggle & Theis Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com
Phone+492206908165
Emailc.winterschladen@spiggle-theis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104250676743473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNZEustachian tube balloon dilation device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-15
Device Publish Date2023-09-07

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04250676744425 - Negus tonsil forceps2025-08-07 slender, wide curve 19 cm
04250676744432 - Negus tonsil forceps2025-08-07 slender, narrow curve 19 cm
04250676744449 - Overholt-Geissdoerfer tonsil forceps2025-08-07 curved 21 cm
04250676744456 - Mikulicz tonsil forceps2025-08-07 curved, 1:2 teeth 18 cm
04250676744463 - Halsted-Mosquito artery forceps2025-08-07 straight, anatomical 12.5 cm

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