FDA.reportPublic FDA data

OCULAR SHIELD

Primary DI
00192896095304
Brand
OCULAR SHIELD
Company
SONTEC INSTRUMENTS, INC.
Model
1100-408MYH
Catalog number
1100-408MYH
Device description
OCULAR SHIELD BILATERAL WITH HANDLE MEDIUM SIZE TRANSPARENT YELLOW PLASTIC
Published
2019-03-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE
MOECollagen Corneal Shield

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1
MOECollagen Corneal ShieldOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896095304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896095304001928960953041928960953040192896095304

GMDN Terms#

Term, Definition table
TermDefinition
Radiation/mechanical corneal shield, reusableA protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable device.

Sterilization Methods#

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

Contacts#

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