FDA.reportPublic FDA data

SteriGear®

Primary DI
00850067913146
Brand
SteriGear®
Company
HR PHARMACEUTICALS INC.
Model
10110
Device description
SteriGear® Image Intensifier/X-ray Tube Drape, 9" II
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
50850067913141PackageGS160In Commercial Distribution
00850067913146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085006791314150850067913141
00850067913146008500679131468500679131460850067913146

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.

Contacts#

Phone, Email table
PhoneEmail
717-252-1110sbenser@hrhealthcare.com

Regulatory Flags#

DUNS number
828918164
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
00850067913054Fig Leaf®102732026-10-15
00850067913061Fig Leaf®102802026-10-15
00850067913078Fig Leaf®102862026-10-15
00850067913085SteriGear®101002026-10-15
00850067913092SteriGear®101012026-10-15
00850067913108SteriGear®101022026-10-15
00850067913115SteriGear®101072026-10-15
00850067913122SteriGear®101082026-10-15
00850067913139SteriGear®101092026-10-15
00850067913153SteriGear®101112026-10-15
00850067913160SteriGear®101122026-10-15
00850067913177SteriGear®101192026-10-15
00850067913184SteriGear®101252026-10-15
00850067913191SteriGear®101262026-10-15
00850067913207SteriGear®101292026-10-15
00850067913214SteriGear®101312026-10-15
00850067913221SteriGear®101322026-10-15
00850067913030Fig Leaf®102702026-10-14
00850067913047Fig Leaf®102722026-10-14
00850067913290NexaFlowUCF1002026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00748426264605Medline-MicrotekMicrotek Medical LLCPUI2026-10-13
00748426264636Medline-MicrotekMicrotek Medical LLCPUI2026-10-13
07467423230682Smith and NephewDAS Medical International SRLPUI2026-10-13
00748426264568Medline-MicrotekMicrotek Medical LLCPUI2026-10-12
16931918199627AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-09-29
10809160538999HalyardMEDICAL ACTION INDUSTRIES INC.PUI2026-09-24
10850091824002AeroKEEHealkee Medical USA Inc.PUI2026-09-24