FDA.reportPublic FDA data

ESP™

Primary DI
08714729735182
Brand
ESP™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001201130
Device description
Radiation Reduction Examination Gloves
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IWPRadiographic protective Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWPRadiographic Protective GloveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729175636PackageGS13In Commercial Distribution
08714729735182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729175636087147291756368714729175636
08714729735182087147297351828714729735182

GMDN Terms#

Term, Definition table
TermDefinition
Radiation attenuating Hevea-latex surgical/procedural gloveA sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical/procedural site; its inner surface is not powdered and the glove's material matrix contains radiation attenuating material intended to limit wearer exposure to incident radiation (e.g., during fluoroscopy). It is used mainly as a two-way barrier to protect patient and staff from contaminants. It will have appropriate characteristics regarding tactility, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010574508APFG65F&L Medical Products LLCIWP2023-11-28
00860010574522APFG75F&L Medical Products LLCIWP2023-11-28
00860010574553APFGXLF&L Medical Products LLCIWP2023-11-28
00860010574515APFG70F&L Medical Products LLCIWP2023-11-27
00860010574539APFG80F&L Medical Products LLCIWP2023-11-27
00860010574546APFG85F&L Medical Products LLCIWP2023-11-27
G031100VRL0Vinyl Lead GlovesShielding International Inc.IWP2023-08-08
G031101MITRL0Lead MittensShielding International Inc.IWP2023-08-08
G031101SLMITRL0Lead Slit MittensShielding International Inc.IWP2023-08-08
G031104OPMRL0Open Palm MittShielding International Inc.IWP2023-08-08
G031104VMRL0Vet MittShielding International Inc.IWP2023-08-08
G031200LRL0200L - Leather Lead GlovesShielding International Inc.IWP2023-08-08
08904333246673UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246680UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246697UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246703UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246710UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246727UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246734UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246741UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246758UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246765UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246772UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246789UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246796UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246802UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246819UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246826UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246833UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246840UniRayUNIRAY MEDICAL LLPIWP2023-02-11