FDA.reportPublic FDA data

3 INCH SELF SEAL POUCH (0033)

Primary DI
00303620000239
Brand
3 INCH SELF SEAL POUCH (0033)
Company
SEPTODONT, INC
Model
01I0033
Device description
3 INCH SELF SEAL POUCH (0033)
Published
2016-09-12
Public version status
Update
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870147000CARERITE & COST RITE NYLON STERILIZATION FILMCost Rite Health Products, Inc.1987-04-23FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00303620000239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00303620000239003036200002393036200002390303620000239

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width3Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(303) 665-7535usregulatoryaffairs@septodont.com

Regulatory Flags#

DUNS number
012925513
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620000628SEPTODONT ETCH 4 X 4GM KIT01C203201C20322016-09-12
00303620000635SEPTODONT USA SEPTOETCH 12-1.6GM SYR01C203401C20342016-09-12
00303620000642SEPTODONT ETCHANT 60GM SYR KIT01C203501C20352016-09-12
00303620000857SEPTODONT HZ IMAGE MH COMP L/C SYR KIT01C20802016-09-12
00303620000949SEPTODONT IMAGE MH L/C REFILL SYRINGE BW01C20932016-09-12
03760140703601R.T.R Membrane9625M2017-07-14
03760140703625R.T.R Membrane 9627O2017-07-14
03760140703618R.T.R Membrane 9626N2017-07-14
00303620000000ASPIJECT SELF ASPIRATING SYRINGE01N202001N20202016-09-15
00303620000017ASPIJECT WITH O-RING01N203001N20302016-09-15
00303620000048SEPTODONT PETITE - BLUE01N210001N21002016-09-12
00303620000055SEPTODONT FUSION(TITANIUM) SYRINGE01N21052016-09-12
00303620000062SEPTODONT STANDARD- GOLD01N211001N21102016-09-12
00303620000079SEPTODONT PINK PETITE ASPIRATING SYRINGE01N212001N21202016-09-12
00303620000086SEPTODONT ECO-A ASPIRATING SYR WINGLESS01N220001N22002016-09-12
00303620000093SEPTODONT ECO-CW ASPIRATING SYR WINGED01N221001N22102016-09-12
00303620000291EARLOOP FACE MASK BLUE 3 PLY (2115)01I21152016-09-12
00303620000307EARLOOP FACE MASK PINK 3 PLY (2116)01I21162016-09-12
00303620000314EARLOOP FACE MASK WHITE 3 PLY (2130)01I21302016-09-12
13760140703608R.T.R Membrane9625M2017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14