FDA.reportPublic FDA data

DEXcam3™ intra-oral camera sheaths

Primary DI
EKAV082269210
Brand
DEXcam3™ intra-oral camera sheaths
Company
DEXIS LLC
Model
0.822.6921
Catalog number
PLU795002
Device description
100 Count
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
EKAV082269210PrimaryHIBCC0
0EKAV082269210Unit of UseHIBCC0

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
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18888833947support@dexis.com

Regulatory Flags#

DUNS number
019717844
Device count
100
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV100879340DEXIS 10 (DEXIS Imaging Suite)101.008.79342022-01-21
EKAV101244750DEXIS™ Software111.012.44752021-11-12
EKAV101289030DEXcam3™ intraoral cameras1.012.89031.012.89032021-11-12
EKAV101289070DEXcam3™ intraoral cameras1.012.89071.012.89072021-11-12
EKAV082250710DEXIS Platinum™ intraoral sensor0.822.5071PLU5101S2016-09-24
EKAV082250730DEXIS Platinum™ intraoral sensor0.822.5073PLU5102C2016-09-24
EKAV082251940DEXIS Platinum™ intraoral sensor0.822.5194PLU6902016-09-24
EKAV100713330DEXcam3™ intraoral cameras1.007.1333PLU7902016-09-24
EKAV100719690DEXcam3™ intraoral cameras1.007.1969PLU7912016-09-24
EKAV100730420DEXIS Platinum™ intraoral sensor1.007.3042PLU5101I2016-09-24
EKAV100898740DEXIS Platinum™ intraoral sensor1.008.9874PLU690K2016-09-24
EKAV100898770DEXIS Platinum™ intraoral sensor1.008.9877PLU690R2016-09-24
EKAV101034080DEXIS™ Software9PLU2362017-04-14
EKAV101034090DEXIS™ Software9PLU2352017-04-14
EKAV101034110DEXIS™ Software9PLU3492017-04-14
EKAV101034120DEXIS™ Software9PLU2382017-04-14
EKAV101135330DEXIS™ Software11101244792016-12-19
EKAV101149840DEXcam4™ Intra-oral camera1.011.4984PLU7602016-09-24
EKAV101149960DEXcam4™ Intra-oral camera1.011.4996PLU7610K2016-09-24
EKAV101184170DEXIS Platinum™ intraoral sensor1.011.8417PLU5109S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819761023063Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023087Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09