FDA.reportPublic FDA data

Patterson Dental, X-Ray Sensor Sheath

Primary DI
D6620708255962
Brand
Patterson Dental, X-Ray Sensor Sheath
Company
TIDI PRODUCTS, LLC
Model
070825596
Catalog number
082-5596
Device description
Patterson X-Ray Sensor Sheath, Size 2, Clear Polyethylene
Published
2023-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EGZHolder, Film, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6620708255964PackageHIBCC5In Commercial Distribution
D6620708255962PrimaryHIBCC0
D6620708255960Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
063519193
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

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00618125135110Grip-Lok3300MWA-NSB3300MWA-NSB2022-10-18
00618125135158Grip-Lok3400L-NSB3400L-NSB2022-10-18
00618125155361SteriGear27344273442022-09-29
10618125192592Grip-Lok3300MWA-NSB3300MWA-NSB2026-06-09
00618125135455Grip-Lok3300MW-TA-33300MW-TA-32022-10-21
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
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D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
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00840456222355JMUJMU DENTAL, INCEGZ2026-06-08
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