FDA.reportPublic FDA data

STERIDENT

Primary DI
B234FRGSSNP400651
Brand
STERIDENT
Company
CPAC EQUIPMENT, INC.
Model
400651
Device description
"SELF-SEAL NYLON POUCHES 3"" 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
B234FRGSSNP400651PrimaryHIBCC0

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
B234FRGSSNP400636STERIDENT4006362018-08-31
B234FRGSSNP400637STERIDENT4006372018-08-31
B234FRGSSNP400638STERIDENT4006382018-08-31
B234FRGSSNP400639STERIDENT4006392018-08-31
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
08404535037654Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
08404535037685Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
00724995239985V. MuellerSteris CorporationFRG2026-10-15
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20884389188269GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188256GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190426GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190453GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115498GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188270GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190440GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389188283GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190484GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115597GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
10884389192481GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196180810GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921093GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921116GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190419GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277115580GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190471GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26