FDA.reportPublic FDA data

Leg Wrap

Primary DI
00840186623446
Brand
Leg Wrap
Company
BURLINGTON MEDICAL, LLC
Model
SBLGW4
Device description
Leg Wrap - Foot Cover to Above Knee .35mm Burlite
Published
2022-09-19
Public version status
New
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
00840186623446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186623446008401866234468401866234460840186623446

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding head wearA personal protective device intended to shield the head of an individual (i.e., the operator or other attending person) from unnecessary primary and scattered radiation during diagnostic or therapeutic medical procedures. It can be shaped like a cap or hood and will typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Head wear used for neutron attenuation is composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083381202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00197513012597TABLEPADAM3085-Q1.5-DBCBVHLA2024-11-22
00197513011958TABLEPADSK3100-Q1.5-DBCBVHLA2024-10-21
00197513011965TABLEPADSK3100-T2.5-DBCBVHLA2024-10-21
00197513011972TABLEPADSK3100-T3-DBCBVHLA2024-10-21
00197513011989TABLEPADAM3080-Q1.5-DBCBVHLA2024-10-21
00197513011996TABLEPADAM3080-T2.5-DBCBVHLA2024-10-21
00197513012009TABLEPADAM3080-T3-DBCBVHLA2024-10-21
00197513012016TABLEPADAM3085-T1.5-DBCBVHLA2024-10-21
00197513012023TABLEPADAM3085-T2.5-DBCBVHLA2024-10-21
00197513012030TABLEPADAM3085-T3-DBCBVHLA2024-10-21
00197513012047TABLEPADSH4900-Q1.5-DBCBVHLA2024-10-21
00197513012054TABLEPADSH4900-T2.5-DBCBVHLA2024-10-21
00197513012061TABLEPADSH4900-T3-DBCBVHLA2024-10-21
00197513012078TABLEPADSK3600-Q1.5-DBCBVHLA2024-10-21
00197513012085TABLEPADSK3600-T2.5-DBCBVHLA2024-10-21
00197513012092TABLEPADSK3600-T3-DBCBVHLA2024-10-21
00197513012108TABLEPADSK6700-Q1.5-DBCBVHLA2024-10-21
00197513012115TABLEPADSK6700-T2.5-DBCBVHLA2024-10-21
00197513012122TABLEPADSK6700-T3-DBCBVHLA2024-10-21
00197513012139TABLEPADSK6701-Q1.5-DBCBVHLA2024-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506025625TheraSphere™BOSTON SCIENTIFIC CORPORATIONKPY2026-03-01
00850061871398IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
00850061871404IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
00850061871411IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
20748426261905Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261929Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261932Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261956Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
05055449412414KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-20
05055449412407KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-07
10748426143075Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
10748426143464DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143440DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143474DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426144273DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00853714008103Steradian ShieldRADUX DEVICES, LLCKPY2025-07-16
30811042030693BLOXRBLOXR Solutions, LLCKPY2025-06-26
10811042030026BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030033BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030040BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030057BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030064BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030071BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030088BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030095BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030101BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030118BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030125BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030132BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030149BLOXRBLOXR Solutions, LLCKPY2025-06-25