FDA.reportPublic FDA data

High Density Lead Glass, Syringe Shield

Primary DI
00718175006122
Brand
High Density Lead Glass, Syringe Shield
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
007-612
Catalog number
007-612
Device description
High Density Lead Glass, Syringe Shield, 10cc and 12cc. Accommodates Luer and Non-Luer Lock Syringes.
Published
2017-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00718175006122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175006122007181750061227181750061220718175006122

GMDN Terms#

Term, Definition table
TermDefinition
Syringe radiation shieldA radiation protective device made to surround a syringe while radioactive material is drawn up into the syringe and during patient injection. It is intended to shield the user from unnecessary exposure to radiopharmaceuticals or other radioactive material used in diagnostic or therapeutic procedures. It is typically made of lead (Pb), lead with a leaded glass insert, or clear lead-equivalent plastic materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175002902LEAD LINED 244-157244-1572020-06-17
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
00718175001486Biodex950-148950-1482023-08-02
00718175005606Sit2Stand950-560950-5602023-07-31
00718175004302VibroTactile950-4302023-07-19
00718175087640BETA, Syringe Shield 007-958007-9582021-01-07
00718175087626VENTI-SCAN IV177-090177-0902020-10-15
00718175087633Aerotech I Radioaerosol Administration System 177-095177-0952020-10-15
00718175002780LEAD LINED 244-136244-1362020-08-26
00718175087619LEAD LINED 244-156244-1562020-08-13
00718175002292LEAD LINED 244-146244-1462020-06-24
00718175004050MJS System 3 Upgrade850-820850-8202017-12-18
00718175002766LEAD LINED 244-206244-2062020-04-13
00718175004708SHIELDED STORAGE CONTAINER050-200050-2002020-04-13
00718175004753SHIELDED STORAGE CONTAINER050-205050-2052020-04-13
00718175004784SHIELDED STORAGE CONTAINER050-250050-2502020-04-13
00718175008478VIAL SHIELD053-610053-6102020-04-13
00718175008614VIAL SHIELD053-611053-6112020-04-13

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Primary DI, Brand, Company table
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05055449412414KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-20
05055449412407KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-07
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