FDA.reportPublic FDA data

NOVATECH® TALCAIR™

Primary DI
EBES109001T0
Brand
NOVATECH® TALCAIR™
Company
NOVATECH
Model
109001T
Catalog number
109001T
Published
2017-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151832000NOVATECH TALCAIRNovatech SA2016-03-31GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBES109001T1PackageHIBCC2In Commercial Distribution
EBES109001T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic spray catheter, single-useA flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal colouration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+33442981560info@novatech.fr

Regulatory Flags#

DUNS number
777211640
Device count
1
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08