FDA.reportPublic FDA data

Digisert

Primary DI
00840252905797
Brand
Digisert
Company
Therafin Corporation
Model
30505
Catalog number
30505
Device description
DIGI-SERT, SHUR GRYP
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840252905797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840252905797008402529057978402529057970840252905797

GMDN Terms#

Term, Definition table
TermDefinition
Rectal medication applicator, reusableA non-sterile instrument intended to be inserted into the rectum for the application of medication to treat haemorrhoids or other conditions of the rectum/anus. It is typically a hollow, plastic device designed to be connected to a tube filled with a cream medication. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-843-7234Info@therafin.com

Regulatory Flags#

DUNS number
056630924
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840252904004Sensory Vest30217302172023-07-06
00840252904011Sensory Vest30218302182023-07-06
00840252904028Sensory Vest30219302192023-07-06
00840252904035Sensory Vest30220302202023-07-06
00840252904042Sensory Cuff30221302212023-07-06
00840252904059Sensory Cuff30222302222023-07-06
00840252904066Sensory Cuff30223302232023-07-06
00840252925597Molded J&L50475504752023-07-06
00840252927423Molded J&L51096510962023-07-06
00840252927454Molded J&L51099510992023-07-06
00840252927461Molded J&L51100511002023-07-06
00840252927478Molded J&L51101511012023-07-06
00840252927485Molded J&L51102511022023-07-06
00840252927492Molded J&L51103511032023-07-06
00840252927508Molded J&L51104511042023-07-06
00840252901089Multi-Axis50215502152023-07-06
00840252901096Surelock50218502182023-07-06
00840252901232ProFit50365503652023-07-06
00840252901249ProFit50366503662023-07-06
00840252901256ProFit50367503672023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00023601023186CarexDrive Devilbiss HealthcareILS2026-04-29
14895262521362HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
14895262521829SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521048HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521390HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521574HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521727SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521304HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521670HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521779SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521578HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521677HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521721SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521776SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521544HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521551HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521159HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521166HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
00194346699421EquateWAL-MART STORES, INC.ILS2026-04-17
04895262521013HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521020HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521037HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521051HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521068HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521044HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-13
00023601023827CarexDrive Devilbiss HealthcareILS2026-04-07
00023601658500CarexDrive Devilbiss HealthcareILS2026-01-12
00023601088215CarexDrive Devilbiss HealthcareILS2025-10-16
00023601088208CarexDrive Devilbiss HealthcareILS2025-06-25
00810178882403ViveVIVE HEALTH LLCILS2025-05-20