FDA.report

DUROSCOPE

Primary DI
00863333000310
Brand
DUROSCOPE
Company
FMD, LLC
Model
LD 2500
Catalog number
LD 2500
Device description
LED Light source
Published
2019-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NTNLed Light Source

Product Code Classifications

CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00863333000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00863333000310008633330003108633330003100863333000310

GMDN Terms

TermDefinition
Camera flash light sourceA device designed to generate and deliver a high-intensity light appropriate for use in a photographic camera flash. It typically consists of an electronic unit with a light (e.g., xenon, halogen) and a fibreoptic cable to transmit the light. The device is used to take endoscopic, microscopic, and other specialized photos.

Sterilization Methods

Method

Regulatory Flags

DUNS number
124947339
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
00863333000303DUROSCOPELC-0507-BLC-0507-B2017-03-09
00863333000327DUROSCOPEHD-101HD-1012019-02-09
00863333000334DUROSCOPEUHD-631UHD-6312019-02-09
00863333000341DUROSCOPELC-0507-CLC-0507-C2017-03-09
00863333000358DUROSCOPECL 150CL 1502019-02-09
86333300030515DUROSCOPELC-0507-BLC-0507-B2017-03-09
86333300030522DUROSCOPELC-0507-CLC-0507-C2017-03-09
86333300030102DUROSCOPE LD 2500LD 25002019-02-09
86333300030188DUROSCOPECL 150CL 1502019-02-09
86333300030218DUROSCOPEHD-101HD-1012019-02-09
86333300030232DUROSCOPEUHD-631UHD-6312019-02-09
86333300030517DUROSCOPELC-0507-BLC-0507-B2017-03-09
86333300030527DUROSCOPELC-0507-CLC-0507-C2017-03-09

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04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
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00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
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