FDA.reportPublic FDA data

BETA, Syringe Shield

Primary DI
00718175087640
Brand
BETA, Syringe Shield
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
007-958
Catalog number
007-958
Device description
BETA, Lead Encapsulated Syringe Shield, 20cc
Published
2021-01-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175087640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175087640007181750876407181750876400718175087640

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175003381SHARPS CONTAINER SHIELD 039-350039-3502019-05-31
00718175003657Neck Phantom 043-365043-3652018-02-15
00718175005002Xenon Rebreathing System 132-680132-6802019-09-30
00718175005019Xenon Rebreathing System 132-681132-6812019-10-16
00718175005040Xenon Rebreathing System 132-690132-6902019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
00718175005088Xenon Rebreathing System 132-770132-7702019-10-16
00718175005101Xenon Rebreathing System 132-774132-7742019-10-17
00718175005125Xenon Rebreathing System 132-784132-7842019-10-16
00718175005132Xenon Rebreathing System 132-793132-7932019-10-16
00718175005149Xenon Rebreathing System 132-771132-7712019-10-16
00718175005156VENTI-SCAN IV177-075177-0752019-12-13
00718175005163AIR CUSHIONED FACE MASK132-685132-6852019-12-13
00718175005170AIR CUSHIONED FACE MASK132-695132-6952019-12-13
00718175005187AIR CUSHIONED FACE MASK132-698132-6982019-12-13
00718175005200BACTERIAL FILTER132-750132-7502019-12-13
00718175005248XENON CONVENIENCE KITS 134-772134-7722019-12-13
00718175002902LEAD LINED 244-157244-1572020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000502COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454000519COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454000526COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454001110COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454001127COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454001134COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002056COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002063COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002087COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002124COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002292COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002452COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454004173COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454004883COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454016176COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454016183COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
00816611026663AngioSystems SorbXANGIOSYSTEMS, INCORPORATEDKPY2026-09-29
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00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08