FDA.reportPublic FDA data

TONN™ NOVATECH®

Primary DI
14063108105520
Brand
TONN™ NOVATECH®
Company
NOVATECH
Model
02BRSB125
Catalog number
02BRSB125
Device description
Basic Block,blue/green/white
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14063108105520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1406310810552014063108105520

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube introducer, reusableA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
777211640
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14063108105162DUTAU NOVATECH02BRD SET2025-02-16
14063108105179DUTAU NOVATECH02BRD SET FR2025-02-16
14063108105186DUTAU NOVATECH02BRD11002025-02-16
14063108105209DUTAU NOVATECH02BRD1100-12025-02-16
14063108105216DUTAU NOVATECH02BRD1100-22025-02-16
14063108105223DUTAU NOVATECH02BRD11102025-02-16
14063108105230DUTAU NOVATECH02BRD11202025-02-16
14063108105247DUTAU NOVATECH02BRD25142025-02-16
14063108105254DUTAU NOVATECH02BRD35092025-02-16
14063108105261DUTAU NOVATECH02BRD35112025-02-16
14063108105278DUTAU NOVATECH02BRD35122025-02-16
14063108105285DUTAU NOVATECH02BRD35142025-02-16
14063108100921TRACHEOBRONXANE™ DUMON®04421S2024-11-22
14063108100938TRACHEOBRONXANE™ DUMON®03721S2024-11-22
14063108100945TRACHEOBRONXANE™ DUMON®03741S2024-11-22
14063108100952TRACHEOBRONXANE™ DUMON®03761S2024-11-22
14063108100969TRACHEOBRONXANE™ DUMON®03781S2024-11-22
14063108100976TRACHEOBRONXANE™ DUMON®03801S2024-11-22
14063108100983TRACHEOBRONXANE™ DUMON®03821S2024-11-22
14063108100990TRACHEOBRONXANE™ DUMON®03841S2024-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407786571FENTEXFENTEX medical GmbHLRC2024-08-01
04250407785765FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785772FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785789FENTEXFENTEX medical GmbHLRC2022-12-15
04250407736866FENTEXFENTEX medical GmbHLRC2022-12-12
04250407736873FENTEXFENTEX medical GmbHLRC2022-12-12
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04250407738105FENTEXFENTEX medical GmbHLRC2022-12-12
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04250407738242FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738259FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738266FENTEXFENTEX medical GmbHLRC2022-12-12