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

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
Primary DIBrandModelCatalogPublished
10841439114732PronumbraRT-C876KRT-C876K2025-09-12
10841439114749PronumbraRT-C878KRT-C878K2025-09-12
10841439114770PronumbraRT-C889KRT-C889K2025-09-12
10841439114787PronumbraRT-C892KRT-C892K2025-09-12
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00840331296488BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
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00840331296501BolleBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296518NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
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00840331296570NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296587NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
00840331296594NikeBURLINGTON MEDICAL, LLCIWS2024-04-12
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