FDA.reportPublic FDA data

Cox II H Eye Shield

Primary DI
00192896109780
Brand
Cox II H Eye Shield
Company
SONTEC INSTRUMENTS, INC.
Model
18-8031R
Device description
Cox II H Eye Shield Offset Handle Small Right Side Stainless Steel 24 X 21 Millimeter
Published
2021-05-13
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
00192896109780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896109780001928961097801928961097800192896109780

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

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
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07
00192896094567ROCHESTER CARMALT FORCEPS1100-150Q1100-150Q2019-03-07
00192896094758BLAKESLEY ETHMOID RONGEUR468-686468-6862019-03-07
00192896095861ETHMOID PEDIATRIC RONGEUR468-590Q468-590Q2019-03-25
00192896041028ETHMOID PEDIATRIC RONGEUR468-580468-5802018-09-10
00192896041035ETHMOID PEDIATRIC RONGEUR468-585468-5852018-09-11
00192896041042ETHMOID PEDIATRIC RONGEUR468-590468-5902018-09-10
00192896041059WILDE ETHMOID RONGEUR468-600468-6002018-09-10
00192896041066WILDE ETHMOID RONGEUR468-606468-6062018-09-11

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
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
00192896095366COX II H EYE SHIELDSONTEC INSTRUMENTS, INC.MOE2019-03-07
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