FDA.reportPublic FDA data

NOVATECH® TALCAIR™

Primary DI
EBES109001T1
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
OTC
false
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 catheterA sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal coloration) 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
777211640
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18