FDA.reportPublic FDA data

SteriGear

Primary DI
10618125183798
Brand
SteriGear
Company
TIDI PRODUCTS, LLC
Model
27397
Device description
Camera Covers Blue Polyurethane Sterile 5.25in x 24in 25 per Case
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
10618125183798PackageGS125In Commercial Distribution
01618125183790PreviousGS10
00618125183791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061812518379810618125183798
01618125183790016181251837901618125183790
00618125183791006181251837916181251837910618125183791

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
true
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
00618125135097Grip-Lok3200S-NSB3200S-NSB2022-10-18
20618125192339AquaGuard50022-CSE50022-CSE2026-07-28
20618125192384AquaGuard50015-CSE50015-CSE2026-07-28
20618125192391AquaGuard50013-CSE50013-CSE2026-07-28
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
03700712438487Maquet OrchideMAQUET SASKQM2026-09-18
03700712438494Maquet OrchideMAQUET SASKQM2026-09-18
10197344213627MEDLINEMEDLINE INDUSTRIES, INC.KQM2026-07-20
00819761023117Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
00819761023124Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
04995047074885CuratOREIZO CORPORATIONKQM2026-06-24
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
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
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
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