FDA.reportPublic FDA data

JAEGER LID PLATE

Primary DI
00192896095823
Brand
JAEGER LID PLATE
Company
SONTEC INSTRUMENTS, INC.
Model
10-4522
Catalog number
10-4522
Device description
"JAEGER LID PLATE SLIGHT ""S"" CURVE LASER FINISH"
Published
2019-03-25
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
GADRetractor
HNIRetractor, Ophthalmic
MOECollagen Corneal Shield

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
HNIRetractor, OphthalmicOphthalmic1
MOECollagen Corneal ShieldOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896095823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896095823001928960958231928960958230192896095823

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.25Inch

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
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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00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
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00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
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00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

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Primary DI, Brand, Company table
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