FDA.reportPublic FDA data

AtoN Optic Only

Primary DI
00851610007114
Brand
AtoN Optic Only
Company
LONG ISLAND TECH
Model
P003248
Device description
Light, Surgical, Endoscopic, Accessory
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSWLight, Surgical, Endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSWLight, Surgical, EndoscopicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851610007114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851610007114008516100071148516100071140851610007114

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030256600
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851610007251BayPort Storage SolutionP0036002020-11-02
00851610007091AtoN Keywest Headlight without Fiber Optic CableP0032672016-09-02
00851610007107HatterasP0027002016-09-02
00851610007121AtoN Classic Headlight without Fiber Optic CableP0032652016-09-02
00851610007138AtoN Classic Headlight with Cobra Fiber Optic CableP0032492016-09-02
00851610007145AtoN Classic Headlight with 10' Fiber Optic CableP0032552016-09-02
00851610007152AtoN Keywest Headlight with Cobra Fiber Optic CableP0032502016-09-02
00851610007169AtoN Keywest Headlight with 10' Fiber Optic CableP0032572016-09-02
00851610007176AtoN Keywest Headlight with 7' Fiber Optic CableP0032622016-09-02
00851610007183AtoN Classic Headlight with 7' Fiber Optic CableP0032602016-09-09
00851610007220Pharos HD HeadcamP0034052021-06-07
00851610007299Fiji HeadbandP0078092021-06-07
00851610007336Pharos HD CCUP0035052021-06-07
00851610007190Dover Headlight OpticP0025052020-12-21
00851610007206Bristol Headlight OpticP0026052020-12-21
00851610007213Daymark Headlight OpticP0031002020-12-21
00851610007268Dover HolsterP0025502020-12-21
00851610007275Bristol HolsterP0025502020-12-21
00851610007282Daymark HolsterP0031502020-12-21
00851610007244BayPort 6-Bay ChargerP0037002020-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704658425PILLINGTELEFLEX INCORPORATEDFSW2019-05-09
14026704658432PILLINGTELEFLEX INCORPORATEDFSW2019-05-09
14026704658449PILLINGTELEFLEX INCORPORATEDFSW2019-05-09
14026704658456PILLINGTELEFLEX INCORPORATEDFSW2019-05-09
00851610007183AtoN Classic Headlight with 7' Fiber Optic CableLONG ISLAND TECHFSW2016-09-09
00851610007091AtoN Keywest Headlight without Fiber Optic CableLONG ISLAND TECHFSW2016-09-02
00851610007107HatterasLONG ISLAND TECHFSW2016-09-02
00851610007121AtoN Classic Headlight without Fiber Optic CableLONG ISLAND TECHFSW2016-09-02
00851610007138AtoN Classic Headlight with Cobra Fiber Optic CableLONG ISLAND TECHFSW2016-09-02
00851610007145AtoN Classic Headlight with 10' Fiber Optic CableLONG ISLAND TECHFSW2016-09-02
00851610007152AtoN Keywest Headlight with Cobra Fiber Optic CableLONG ISLAND TECHFSW2016-09-02
00851610007169AtoN Keywest Headlight with 10' Fiber Optic CableLONG ISLAND TECHFSW2016-09-02
00851610007176AtoN Keywest Headlight with 7' Fiber Optic CableLONG ISLAND TECHFSW2016-09-02