FDA.reportPublic FDA data

Paneffort

Primary DI
10810101310949
Brand
Paneffort
Company
Paneffort, LLC
Model
SMS-SET-1M
Device description
Disposable Scrub Set. Short Sleeve Scrub Shirt. Elastic Waist Pant with Pockets, Blue. Medium
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810101310949PrimaryGS10
00810101310942Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010131094910810101310949
00810101310942008101013109428101013109420810101310942

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
1-800-518-1264service@paneffort.com

Regulatory Flags#

DUNS number
018250858
Device count
100
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810101310550Paneffort421462023-04-05
20810101310106PaneffortSMGL3-FBTN-1R2024-12-18
20810101310335PaneffortSMGL3-FBTN-1X2024-12-18
00810101311154DinamicOR111-3223d2025-06-12
00810101311147DinamicOR111-2112d2025-06-12
10810101311151DinamicOR111-3223d2025-06-12
00810101310102PaneffortSMGL3-FBTN-1R2024-12-18
00810101310331PaneffortSMGL3-FBTN-1X2024-12-18
10810101310918PaneffortSMS-SET-12X2024-09-27
10810101310956PaneffortSMS-SET-1S2024-09-27
20810101310960PaneffortSMS-SET-1X2024-09-27
00810101310911PaneffortSMS-SET-12X2024-09-27
00810101310942PaneffortSMS-SET-1M2024-09-27
00810101310959PaneffortSMS-SET-1S2024-09-27
00810101310966PaneffortSMS-SET-1X2024-09-27
10810101310482PaneffortACF-FMHB-9RU2022-06-03
00810101310362DinamicOR111-32232024-08-05
00810101311116DinamicOR111-21122024-08-05
10810101310369DinamicOR111-32232024-08-05
10810101311113DinamicOR111-21122024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832CT10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
20197344158895MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158918MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158932MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158956MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18