visionPRO Mac 4

GUDID 04053755200054

Heine Optotechnik GmbH & Co. KG

Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use Laryngoscope blade, single-use
Primary Device ID04053755200054
NIH Device Record Keydf7e79ef-c37d-49a5-a8a7-81de863839a7
Commercial Distribution StatusIn Commercial Distribution
Brand NamevisionPRO Mac 4
Version Model Number000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
GS104053755199938 [Primary]
GS104053755200054 [Package]
Contains: 04053755199938
Package: box [10 Units]
In Commercial Distribution
GS104053755200078 [Package]
Contains: 04053755199938
Package: box [50 Units]
In Commercial Distribution

FDA Product Code

CCWLaryngoscope, Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-17
Device Publish Date2022-11-09

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04053755202133 - K180 LED F.O. OTOSCOPE 2024-07-05
04053755202232 - K 180 LED OPHTHALMOSCOPE2024-07-05
04053755114658 - BETA 200 OTOSCOPE2024-06-28 since 2024-05 in LED version: BETA 200 LED F.O. OTOSCOPE
04053755114696 - K 180 OTOSCOPE2024-06-28 since 2024-05 in LED version: K180 LED OTOSCOPE
04053755119981 - BETA 200 OPHTHALMOSCOPE2024-06-28 since 2024-05 in LED version: BETA 200 LED OPHTHALMOSCOPE
04053755120000 - BETA 200 S OPHTHALMOSCOPE2024-06-28 since 2024-05 in LED version: BETA 200S LED OPHTHALMOSCOPE 2.5V

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