FDA.report

KENEX

Primary DI
05055449402385
Brand
KENEX
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
312/DS/3.128
Catalog number
312/DS/3.128
Device description
312/DS/3.128 57x24cm High Lift Off Top Shield - TYPE 2
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KPYShield, Protective, Personnel

Product Code Classifications

CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055449402385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055449402385050554494023855055449402385

GMDN Terms

TermDefinition
Radiation shielding curtainA flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material.

Sterilization Methods

Method

Regulatory Flags

DUNS number
217421064
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
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

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05055449412438Kenex351/68/LED130F-0031351/68/LED130F-00312026-02-09
05055449412414Kenex312/E-020/3/P312/E-020/3/P2026-01-20
05055449412407Kenex313/A2-025313/A2-0252026-01-07
05055449409933Kenex354/P/76-107354/P/76-1072025-06-09
05055449412223Kenex354/P/76-207354/P/76-2072025-06-06
05055449405522KENEX312/E-023/P312/E-023/P2025-02-24
05055449412087KENEX313/A2-023313/A2-0232025-02-24
05055449412070KENEX312/DS-0412/4312/DS-0412/42025-01-13
05055449412063KENEX313/A2-022313/A2-0222025-01-06
05055449411950KENEX312/E-017312/E-0172024-12-09
05055449411967KENEX312/E-017/8312/E-017/82024-12-09
05055449411974KENEX312/E-017/P312/E-017/P2024-12-09
05055449411981KENEX312/E-017/8P312/E-017/8P2024-12-09
05055449411998KENEX312/DS-039/4/3312/DS-039/4/32024-12-09
05055449412001KENEX312/DS-039/4312/DS-039/42024-12-09
05055449412018KENEX351/LR/80/SP/30351/LR/80/SP/302024-12-09
05055449412025KENEX333/OPT-006333/OPT-0062024-12-09
05055449415705KENEX1330/51330/52022-12-08
05055449415910KENEX1330/31330/32022-12-08
05055449415934KENEX1330/41330/42022-12-08

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