FDA.reportPublic FDA data

STERIDENT

Primary DI
B234FRGSSNP400636
Brand
STERIDENT
Company
CPAC EQUIPMENT, INC.
Model
400636
Device description
"Self-Seal Nylon Pouches 2"" x 10"" 100/Box"
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110867000STERI-DENT, STERI-SURECpac, Inc.2011-07-20FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B234FRGSSNP400636PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601985976
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B234FRGDHIS400635STERIDENT4006352018-09-20
B234KMHRHPRO111230V1RH-Pro11-230VRH-PRo11-230V2020-10-01
B234KMHRHPRO9115V3RH-Pro9RH-Pro92020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VRH-Pro9-230V2020-10-01
B234FRGSSNP400637STERIDENT4006372018-08-31
B234FRGSSNP400638STERIDENT4006382018-08-31
B234FRGSSNP400639STERIDENT4006392018-08-31
B234FRGSSNP400651STERIDENT4006512018-08-31
B234JCXPD101008115PORTODENT1010082018-08-31
B234JCXPD101009230PORTODENT1010092018-08-31
B234JCXPD101125115PORTODENT1011252018-08-31
B234KMHCX6000115V150COX RAPIDHEAT6000COX-115V-152018-07-31
B234KMHCX6000115V161COX RAPIDHEAT6000-16COX-115V-162018-08-23
B234KMHCX6220230V152COX RAPIDHEAT6220COX-230V-152018-08-24
B234KMHCX6220230V163COX RAPIDHEAT6220COX-230V-162018-08-24
B234KMHRHPRO111115V0RH-Pro11RH-Pro112019-01-18
B234KMHSD201000115STERIDENT2002018-08-31
B234KMHSD201000230STERIDENT2002018-08-31
B234KMHSD301000115STERIDENT3002018-08-31
B234KMHSD301000230STERIDENT3002018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05
00840456201930JMUJMU DENTAL, INCFRG2026-06-05
00840456201947JMUJMU DENTAL, INCFRG2026-06-05
00840456202951JMUJMU DENTAL, INCFRG2026-06-05
00840456202968JMUJMU DENTAL, INCFRG2026-06-05
00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05