DELTA X CPG K-000.34.238

GUDID 04053755203338

contact plate

Heine Optotechnik GmbH & Co. KG

Dermatoscope, optical
Primary Device ID04053755203338
NIH Device Record Key0b44a41e-b4d5-4928-8a34-2d923d62e0b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDELTA X CPG
Version Model Number00
Catalog NumberK-000.34.238
Company DUNS315274563
Company NameHeine Optotechnik GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104053755203338 [Primary]

FDA Product Code

KYTLight, Examination, Medical, Battery Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-11
Device Publish Date2025-12-03

Devices Manufactured by Heine Optotechnik GmbH & Co. KG

04053755203314 - DELTA X2025-12-11 Set containing contact plates and power supply E4-USB
04053755203321 - DELTA X CPP2025-12-11 contact plate
04053755203338 - DELTA X CPG2025-12-11contact plate
04053755203338 - DELTA X CPG2025-12-11 contact plate
04053755202744 - BETA X Otoscope2025-07-28 Set containing X CHANGE System 4.2 x Magnifier, 10 x AllSpec 4 mm disposable tips
04053755202973 - FINOFF TRANSILLUMINATOR2025-07-25
04053755202966 - BETA X OPHTHALMOSCOPE2025-07-25
04053755203048 - GAMMA 3.22025-07-25 GAMMA 3.2 ACOUSTIC X-Serie
04053755202928 - DELTAone2025-05-08

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