FDA.reportPublic FDA data

COX II H EYE SHIELD

Primary DI
00192896095366
Brand
COX II H EYE SHIELD
Company
SONTEC INSTRUMENTS, INC.
Model
18-8032L
Catalog number
18-8032L
Device description
COX II H EYE SHIELD MEDIUM SIZE OFFSET LEFT SIDE STAINLESS STEEL
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
MOECollagen Corneal Shield

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOECollagen Corneal ShieldOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896095366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896095366001928960953661928960953660192896095366

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845819005699SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005705SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005774SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005781SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00845819005798SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005696SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005702SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005771SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005788SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
10845819005795SOFT SHIELD® Collagen ShieldsOASIS MEDICAL, INC.MOE2023-06-30
00192896109773Cox II H Eye ShieldSONTEC INSTRUMENTS, INC.MOE2021-05-13
00192896109780Cox II H Eye ShieldSONTEC INSTRUMENTS, INC.MOE2021-05-13
00192896103382Eye ShieldSONTEC INSTRUMENTS, INC.MOE2020-07-13
00192896103399Eye ShieldSONTEC INSTRUMENTS, INC.MOE2020-07-13
00192896099999COX II EYE SHIELD SONTEC INSTRUMENTS, INC.MOE2019-11-05
00192896100008COX II EYE SHIELD SONTEC INSTRUMENTS, INC.MOE2019-11-05
00192896095823JAEGER LID PLATESONTEC INSTRUMENTS, INC.MOE2019-03-25
00192896095830SUCTION CUP HANDLESONTEC INSTRUMENTS, INC.MOE2019-03-25
00192896095373COX II H EYE SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095250OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095267OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095274OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095281OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095298OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095304OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095311OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095328OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095335OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896095342OCULAR SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
00192896075160EYE SHIELDSONTEC INSTRUMENTS, INC.MOE2018-10-04