FDA.reportPublic FDA data

DermLite DL5 Pouch

Primary DI
00850017651470
Brand
DermLite DL5 Pouch
Company
DermLite LLC
Model
DL5-P
Catalog number
DL5-P
Device description
Genuine leather belt pouch for DL5 series
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017651470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017651470008500176514708500176514700850017651470

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, opticalAn electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-481-6384p.wojtaszek@dermlite.com

Regulatory Flags#

DUNS number
104621896
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017651012DL2 Silicone SleeveDLIISSDLIISS2024-06-20
00850017651029MagnetiConnect for all phone/tablet adaptersDLMCDLMC2024-06-20
00850017651036MagnetiConnect Adapter - 37 mmDLMC-37DLMC-372024-06-20
00850017651043MagnetiConnect Adapter - 52 mmDLMC-52DLMC-522024-06-20
00850017651067MagnetiConnect for Nikon 1 AW1DLMC-N1DLMC-N12024-06-20
00850017651074DL200/Lumio S Drawstring PouchDSPDSP2024-06-20
00850017651081FOTO Cable (Head to PowerPack)FOTO-CABLEFOTO-CABLE2024-06-20
00850017651098PowerPack ChargerFOTO-CHARGERFOTO-CHARGER2024-06-20
00850017651104DermLite GL BatteryGLBGLB2024-06-20
00850017651111IceCap for DL200, 100-packICDL200-100ICDL200-1002024-06-20
00850017651128IceCap for DL4 & Foto X, 100-packICDL4-100ICDL4-1002024-06-20
00850017651135IceCap Covers for Nailio, 50-packICNL1-50ICNL1-502024-06-20
00850017651142DL4/DL200 USB CableMUSBMUSB2024-06-20
00850017651159Foto X/GL USB-C CableMUSB-CMUSB-C2024-06-20
00850017651166Lumio 2 BatteryDLU2BDLU2B2024-06-20
00850017651173Lumio 2 +2.5x Lens AccessoryDLU2-1240DLU2-12402024-06-20
00850017651180Lumio 2 495nm Longpass FilterDLU2-1230DLU2-12302024-06-20
00850017651197DL handyscope Faceplate - blankFFH2-1238FFH2-12382024-06-20
00850017651203DL handyscope Faceplate - markedFFH2-1240FFH2-12402024-06-20
00850017651210DL handyscope Soft CaseFFH2-1609FFH2-16092024-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
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B366LED0204PORTALEDEclerisKYT2026-01-23
04053755203314DELTA XHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203321DELTA X CPPHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203338DELTA X CPGHeine Optotechnik GmbH & Co. KGKYT2025-12-03
00851289007347FireflyFirefly GlobalKYT2025-07-18
04053755202928DELTAoneHeine Optotechnik GmbH & Co. KGKYT2025-04-30
07465850912003Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912010Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912027Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912034Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912041Dr. VampaDr Vampa S.R.L.KYT2025-03-10
00814005023526RADBL25Quality Aspirators, Inc.KYT2025-02-27
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00814005023540RADFILM5Quality Aspirators, Inc.KYT2025-02-27
00814005023571RADHU2Quality Aspirators, Inc.KYT2025-02-27
00814005023595RADHUM4Quality Aspirators, Inc.KYT2025-02-27
00814005023618RADINST1Quality Aspirators, Inc.KYT2025-02-27
00814005024172RADC25Quality Aspirators, Inc.KYT2025-02-27
00814005024189RADFILM6Quality Aspirators, Inc.KYT2025-02-27
008140050242572 Pin Detachable CableQuality Aspirators, Inc.KYT2025-02-27
00814005024288M-CZQuality Aspirators, Inc.KYT2025-02-27
00814005024295M-ORTTL AssemblyQuality Aspirators, Inc.KYT2025-02-27
00814005024301M-COQuality Aspirators, Inc.KYT2025-02-27
00814005024370M-KEQuality Aspirators, Inc.KYT2025-02-27
00814005024387M-HBQuality Aspirators, Inc.KYT2025-02-27
00814005024394M-ORQuality Aspirators, Inc.KYT2025-02-27
00814005024400M-QFQuality Aspirators, Inc.KYT2025-02-27
00814005024431M-SUQuality Aspirators, Inc.KYT2025-02-27