FDA.reportPublic FDA data

SteriGear

Primary DI
00618125155361
Brand
SteriGear
Company
TIDI PRODUCTS, LLC
Model
27344
Catalog number
27344
Device description
SteriGear C-arm Equipment Covers Clear Polyethylene Sterile 42in x 74in x 1in 20 per Case
Published
2022-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10618125155368PackageGS120In Commercial Distribution
01618125155360PreviousGS10
00618125155361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061812515536810618125155368
01618125155360016181251553601618125155360
00618125155361006181251553616181251553610618125155361

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
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
false
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
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
00618125134533Grip-Lok3360MWA3360MWA2022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264593Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264623Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20888277636597MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20888277636627MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14