Fiber Optic Light Guide TR9801-61

GUDID 10853480006058

Fiber optic light probe for intraocular illumination with tissue manipulation. 45 ° Light Pick, 20 ga, with TREK/Greishabler connector. Sterile, single-use.

ESCALON MEDICAL CORP.

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID10853480006058
NIH Device Record Key196b20d0-b89d-41b4-9864-ee541f5f74b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiber Optic Light Guide
Version Model Number45°, 20 ga, TREK/Greishaber
Catalog NumberTR9801-61
Company DUNS879144426
Company NameESCALON MEDICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-486-4848
Emailinfo@escalonmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853480006051 [Primary]
GS110853480006058 [Package]
Contains: 00853480006051
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSTLight, Surgical, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2016-01-14

On-Brand Devices [Fiber Optic Light Guide]

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10853480006119DCR illuminated fiber optic light probe for transillumination of tissue. 20 ga, with Universal
10853480006102Siepser shielded fiber optic light probe for identifying debris and fibers in the corneal interf
10853480006096Wide angle fiber optic light probe for wide view intraocular illumination. Wide angle light gui
10853480006089Wide angle fiber optic light probe for wide view intraocular illumination. Wide angle light gui
10853480006072Fiber optic light probe for intraocular illumination with tissue manipulation. 45 degree Retina
10853480006065Fiber optic light probe for intraocular illumination with tissue manipulation. 45° Retinal Kni
10853480006058Fiber optic light probe for intraocular illumination with tissue manipulation. 45 ° Light Pick
10853480006041Fiber optic light probe for intraocular illumination with tissue manipulation. 45° Light Pick,
10853480006034Fiber optic light probe for intraocular illumination. Standard light guide, 20 ga, with Trek/Gr

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