FDA.reportPublic FDA data

Sterimed

Primary DI
07466532979888
Brand
Sterimed
Company
DAS Medical International SRL
Model
PC0796
Catalog number
PC0796
Device description
"Probe Cover 7"" x 96” "
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
17466532979885PackageGS18In Commercial Distribution
27466532979882PackageGS125In Commercial Distribution
07466532979888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1746653297988517466532979885
2746653297988227466532979882
07466532979888074665329798887466532979888

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1 809-556-8900dfulgencio@ufpt.com
1 809-556-8900lrondon@ufpt.com

Regulatory Flags#

DUNS number
817435655
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07466532979338Moon Surgical3003002026-05-28
74665329793382Moon Surgical3003002025-04-24
17467423230054Sterimed0986B0986B2025-12-12
17467423230078Sterimed4425B4425B2025-12-12
17467423230139SterimedAR1096-2AR1096-22025-12-12
07466532979772SterimedZB0096ZB00962025-12-12
07466532979789SterimedZB1005ZB10052025-12-12
07466532979802SterimedWR1010WR10102025-12-12
07466532979857SterimedPC0524PC05242025-12-12
07466532979864SterimedPC0548PC05482025-12-12
07466532979871SterimedPC0596PC05962025-12-12
17466532979779SterimedZB0096ZB00962025-12-12
17466532979786SterimedZB1005ZB10052025-12-12
17466532979762SterimedWR1010WR10102025-12-12
17466532979854SterimedPC0524PC05242025-12-12
17466532979861SterimedPC0548PC05482025-12-12
17466532979878SterimedPC0596PC05962025-12-12
17466532979885SterimedPC0796PC07962025-12-12
27467423230051Sterimed0986B0986B2025-12-12
27467423230075Sterimed4425B4425B2025-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10192253066586CONVERTORSCardinal Health 200, LLCPUI2025-11-07
10192253066531CONVERTORSCardinal Health 200, LLCPUI2025-09-24
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10192253066494CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066500CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066517CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066524CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066548CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066555CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066562CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066579CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066593CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066609CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066616CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066623CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066654CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066692CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066708CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253050233CONVERTORSCardinal Health 200, LLCPUI2024-09-10
10192253050240CONVERTORSCardinal Health 200, LLCPUI2024-09-10
10080196073351MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-24
10080196739240MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-12
10080196313846MedlineMEDLINE INDUSTRIES, INC.PUI2023-06-08
10080196744626MedlineMEDLINE INDUSTRIES, INC.PUI2023-06-08
10080196283248MedlineMEDLINE INDUSTRIES, INC.PUI2023-01-06
10080196746842MedlineMEDLINE INDUSTRIES, INC.PUI2023-01-06