FDA.reportPublic FDA data

Zero Gravity

Primary DI
00618125176076
Brand
Zero Gravity
Company
TIDI PRODUCTS, LLC
Model
ZGAV-M
Catalog number
ZGAV-M
Device description
Medium Vest; Accessory Intended for Use with Zero Gravity Radiation Protection System
Published
2022-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EAJApron, Leaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618125176076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125176076006181251760766181251760760618125176076

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063519193
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618125134724Grip-Lok3300M-NSB3300M-NSB2022-10-18
10618125134707Grip-Lok3200S-10PK3200S-10PK2022-10-12
10618125134714Grip-Lok3300M-10PK3300M-10PK2022-10-12
10618125134769Grip-Lok3400L-10PK3400L-10PK2022-10-12
10618125134783Grip-Lok3400LFC-10PK3400LFC-10PK2022-10-13
10618125135148Grip-Lok3309MCS-TA-NSB3309MCS-TA-NSB2024-04-22
10618125192141Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
10618125192172Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
10618125192585Grip-LokMCGLPICC-NSBMCGLPICC-NSB2026-04-15
28481750004016Mermaid MedicalA20100090A201000902022-10-12
00618125134526Grip-Lok3460L3460L2022-10-19
00618125134533Grip-Lok3360MWA3360MWA2022-10-19
00618125134687Grip-Lok3300MEPI3300MEPI2022-10-12
00618125134717Grip-Lok3300M-10PK3300M-10PK2023-06-29
00618125134748Grip-Lok3300MWA3300MWA2022-10-12
00618125134779Grip-Lok3400LFC3400LFC2022-10-13
00618125134809Grip-Lok2200NUZA2200NUZA2022-10-12
00618125134816Grip-Lok3300MIV3300MIV2022-10-12
00618125134823Grip-Lok3301MCS-BD3301MCS-BD2022-10-12
00618125134847Grip-Lok3303MCS-TA3303MCS-TA2022-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031QRSOMFRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-22
G031SO2XFRL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XFRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XFTL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMNL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMRL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMTL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFNL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFRL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFTL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMNL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMRL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMTL0SkirtShielding International Inc.EAJ2026-04-22
G031SOMFNL0SkirtShielding International Inc.EAJ2026-04-22
G031SOMFRL0SkirtShielding International Inc.EAJ2026-04-22
G031SOMFRLL0SkirtShielding International Inc.EAJ2026-04-22