FDA.reportPublic FDA data

Synalax

Primary DI
00850325006405
Brand
Synalax
Company
Cristcot LLC
Model
Synalax
Device description
Synalax 3 pack with 3 Sephure suppository applicators
Published
2021-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOWApplicator For Rectal Suppository

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOWApplicator For Rectal SuppositoryGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092829000INSERTEASEChristcot Medical Company2009-12-02OOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850325006405PrimaryGS10
00868648000000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850325006405008503250064058503250064050850325006405
00868648000000008686480000008686480000000868648000000

GMDN Terms#

Term, Definition table
TermDefinition
Rectal medication applicator, single-useA non-sterile instrument intended to be inserted into the rectum for the application of medication to treat local or systemic disease/conditions. It is a plastic device which may be in the form of a short tube to be connected to a cream medication tube, or a fluted tube with a plunger to administer a suppository. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
978-212-6380info@sephure.com

Regulatory Flags#

DUNS number
080739421
Device count
3
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850325006429Sephure® suppository applicatorD0-62021-09-28
00868648000031Sephure® suppository applicatorA2-102021-09-28
00868648000048Sephure® suppository applicatorB3-102021-09-28
00868648000055Sephure® suppository applicatorA2-302021-09-28
00850325006320Sephure® suppository applicatorD02021-09-28
00868648000017Sephure® suppository applicatorB32021-09-28
00868648000000Sephure® suppository applicatorA22021-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850325006429Sephure® suppository applicatorCristcot LLCOOW2021-09-28
00868648000031Sephure® suppository applicatorCristcot LLCOOW2021-09-28
00868648000048Sephure® suppository applicatorCristcot LLCOOW2021-09-28
00868648000055Sephure® suppository applicatorCristcot LLCOOW2021-09-28
00850325006320Sephure® suppository applicatorCristcot LLCOOW2021-09-28
00868648000017Sephure® suppository applicatorCristcot LLCOOW2021-09-28
00868648000000Sephure® suppository applicatorCristcot LLCOOW2021-09-28