FDA.reportPublic FDA data

Dentrix

Primary DI
10618125126276
Brand
Dentrix
Company
TIDI PRODUCTS, LLC
Model
20955
Catalog number
6149004
Device description
XIOS Plus Hygienic Covers Size 2
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
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
10618125126276PackageGS1300In Commercial Distribution
00618125126279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061812512627610618125126276
00618125126279006181251262796181251262790618125126279

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063519193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00618125134533Grip-Lok3360MWA3360MWA2022-10-19
00618125134687Grip-Lok3300MEPI3300MEPI2022-10-12
00618125134717Grip-Lok3300M-10PK3300M-10PK2023-06-29
00618125134748Grip-Lok3300MWA3300MWA2022-10-12
00618125134779Grip-Lok3400LFC3400LFC2022-10-13
00618125134809Grip-Lok2200NUZA2200NUZA2022-10-12
00618125134816Grip-Lok3300MIV3300MIV2022-10-12
00618125134823Grip-Lok3301MCS-BD3301MCS-BD2022-10-12
00618125134847Grip-Lok3303MCS-TA3303MCS-TA2022-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2026-05-15
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
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
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
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2025-02-28
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2024-06-11
06932503563703eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09
06932503563765eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09
14714127861392AESCULAPAesculap AGKQM2023-11-05