FDA.reportPublic FDA data

Eye Shield

Primary DI
00841439107768
Brand
Eye Shield
Company
MEDTEC, INC.
Model
MTT45L
Catalog number
MTT45L
Device description
Eye Shield - Large
Published
2018-08-06
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
IWSShield, eye, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWSShield, Eye, RadiologicalRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945515000COATED TUNGSTEN EYESHIELDMedtec, Inc.1995-06-19IWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439107768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439107768008414391077688414391077680841439107768

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
Length1.17Inch
Width1.1Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(712)737-8688radiotherapy.complaints@civcort.com

Regulatory Flags#

DUNS number
103977526
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00841439115114BioXmark112105902025-07-01
00841439109571Marker Placement NeedleMTNW887351MTNW8873512017-08-02
00841439109588Marker Placement NeedleMTNW887358MTNW8873582017-08-02
00841439109595Coupled™ Fiducial Marker KitMTNW887709MTNW8877092017-08-02
00841439109601Coupled™ Fiducial Marker KitMTNW887710MTNW8877102017-08-02
00841439109618Coupled™ Fiducial Marker KitMTNW887711MTNW8877112017-08-02
00841439109625Coupled™ Fiducial Marker KitMTNW887712MTNW8877122017-08-02
00841439109632Fiducial MarkersMTNW887805MTNW8878052017-08-02
00841439109649Fiducial MarkersMTNW887808MTNW8878082017-08-02
00841439109656Fiducial MarkersMTNW887809MTNW8878092017-08-02
00841439109663Fiducial Marker KitMTNW887810MTNW8878102017-08-02
00841439109670Fiducial MarkersMTNW887812MTNW8878122017-08-02
00841439109687Fiducial MarkersMTNW887814MTNW8878142017-08-02
00841439109694Fiducial Marker KitMTNW887825MTNW8878252017-08-02
00841439109700Fiducial Marker KitMTNW887830MTNW8878302017-08-02
00841439109717Fiducial Marker KitMTNW887835MTNW8878352017-08-02
00841439109724Fiducial Marker KitMTNW887836MTNW8878362017-08-02
00841439109731Fiducial Marker KitMTNW887837MTNW8878372017-08-02
00841439109748Fiducial Marker KitMTNW887840MTNW8878402017-08-02
00841439109755Fiducial Marker KitMTNW887851MTNW8878512017-08-02

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