FDA.reportPublic FDA data

Medline-Microtek

Primary DI
10748426147721
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Probe Covers
Catalog number
PC1355NS
Device description
Endocavity Probe Cover, 10 cm x 4.4 cm x 25 cm (4 in x 2 in x 10 in)
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10748426147721PackageGS150In Commercial Distribution
00748426147724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074842614772110748426147721
00748426147724007484261477247484261477240748426147724

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, basicA sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
106908437
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426121861OLYMPUSEquipment DrapesOME-V2-D2026-05-28
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426262076AQUABLATION THERAPY®Patient DrapesDR39002026-04-06
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
00748426261543NA33206633202026-02-26
10748426261540NA33206633202026-02-26
10748426144294Medline-MicrotekEquipment Drapes5096NS2026-02-18
10748426144560Medline-MicrotekEquipment Drapes15427-002026-02-18
10748426144584Medline-MicrotekEquipment Drapes2904N2026-02-18
10748426144591Medline-MicrotekEquipment Drapes4604N2026-02-18
10748426144607Medline-MicrotekEquipment Drapes4650N2026-02-18
10748426144614Medline-MicrotekEquipment Drapes4954N2026-02-18

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