FDA.reportPublic FDA data

Eye Shield

Primary DI
00841439107782
Brand
Eye Shield
Company
MEDTEC, INC.
Model
MTT45S
Catalog number
MTT45S
Device description
Eye Shield - Small
Published
2017-08-02
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
00841439107782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439107782008414391077828414391077820841439107782

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
Length0.91Inch
Width0.84Inch

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
Primary DIBrandModelCatalogPublished
00841439113059Registration FilmPRO340PRO3402019-10-10
00841439114032Pediatric Registration FilmPRO440PRO4402022-08-20
00841439113240Solstice™ MR SRS Immobilization SystemCHS04MRCHS04MR2020-07-10
00841439110904RediFoam™MTFA41BMTFA41B2017-08-02
00841439110911RediFoam™MTFA40BMTFA40B2017-08-02
00841439110928RediFoam™MTFA39BMTFA39B2017-08-02
00841439101056Low Kneefix™ 23010483010482017-08-02
00841439101070Kneefix™ 33010523010522017-08-02
00841439101124Feetfix™ 33010713010712017-08-02
00841439102374Uni-frame® BaseplateMT20100MT201002017-08-02
00841439102411Uni-frame® BaseplateMT20104MT201042017-08-02
00841439102428Uni-frame® BaseplateMT20108MT201082017-08-02
00841439104163Type-S™ Variable Axis BaseplateMTCFHNVAB01MTCFHNVAB012017-08-02
00841439107003Prone-Lok™ Positioning CushionMTPLC01MTPLC012017-08-02
00841439109939Type-S™ Overlay1080731080732017-08-02
00841439110621Posifix® Variable Axis Baseplate1070651070652017-08-02
00841439111956Vac-Lok™ CushionVLWGB03VLWGB032018-05-07
00841439111963Vac-Lok™ CushionVLPLV02VLPLV022018-05-07
00841439111970Vac-Lok™ CushionVLPLV01VLPLV012018-05-07
00841439111987Vac-Lok™ CushionVLJ20VLJ202018-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840331296310NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296327NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296334NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296341NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296358BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296365BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296372BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296389BomberBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296396HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296402HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296419HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296426HavenBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296433NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296440NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296457NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296464NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296471BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296488BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296495BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296501BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296518NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296525NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296532NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296549NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296556NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296563NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296570NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296587NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296594NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296600NikeBURLINGTON MEDICAL, LLCIWS2024-04-12