FDA.reportPublic FDA data

Hygienic Sheaths

Primary DI
40889971067490
Brand
Hygienic Sheaths
Company
CARESTREAM HEALTH, INC.
Model
Hygienic Sheaths
Catalog number
1067495
Device description
Hygienic Sheaths #0 - 200 Pcs
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971067494PackageGS110In Commercial Distribution
40889971067490PrimaryGS10
00889971067492Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6088997106749460889971067494
4088997106749040889971067490
00889971067492008899710674928899710674920889971067492

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor/probe cover, sterileA sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Regulatory Flags#

DUNS number
793169512
Device count
200
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889976701171CARESTREAM Image SuiteCARESTREAM Image Suite67011712022-02-25
60889971001894Vue Cardio PACSVue Cardio PACS10018902016-09-16
60889971029881DRX - Ascend SystemDRX - Ascend System10298832017-07-24
60889971041692Vue PACSVue PACS12012842016-09-16
60889971047809Vue PACSVue PACS11494182016-09-16
60889971048875Vue MotionVue Motion10179792016-09-16
60889971055989CARESTREAM Image SuiteCARESTREAM Image Suite10559872016-09-16
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
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10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
05415334001336BARCOBarco NVKQM2024-05-30
04251303302254CuratOREIZO GmbHKQM2024-02-08
14714127861392AESCULAPAesculap AGKQM2023-11-05
06973786290139lmaging Processor System (lncluding Light Source)Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)KQM2023-07-26