FDA.reportPublic FDA data

Colibri micro-ENT Scope

Primary DI
17290016539223
Brand
Colibri micro-ENT Scope
Company
3NT MEDICAL LTD
Model
ERW-0200
Catalog number
ERW-0200
Device description
Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
Published
2023-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192305000Colibri Endoscopy System3nt Medical , Ltd.2020-02-27EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016539223PackageGS110In Commercial Distribution
57290016539221PackageGS15In Commercial Distribution
07290016539226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001653922317290016539223
5729001653922157290016539221
07290016539226072900165392267290016539226

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video otorhinolaryngoscopeAn endoscope with a rigid inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600235289
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016539226Colibri micro-ENT ScopeERW-0200ERW-02002023-12-31
07290016539103Colibri micro ENT scopeERW-0100ERW-01002020-05-21
07290016539073Peregrine drivable ENT scopeSWY-0100SWY-01002023-01-31
072900165392023NT Video Console 2CCU-0200CCU-02002021-02-21
072900165390973NT Video ConsoleCCU-0100CCU-01002020-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04953170467592DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EOB2024-11-14
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
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06970462546443Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546191Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
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00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22