FDA.reportPublic FDA data

Lacrimal Probe

Primary DI
00192896103344
Brand
Lacrimal Probe
Company
SONTEC INSTRUMENTS, INC.
Model
16-2491
Device description
French Pattern Lacrimal Probe Bayonet Shaped Size No. 1
Published
2020-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNWDilator, lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896103344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896103344001928961033441928961033440192896103344

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
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00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
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Primary DI, Brand, Company table
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