Sephure® suppository applicator

GUDID 00868648000000

A2 30-pouch - rectal suppository applicator, USA

Cristcot LLC

Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use Rectal medication applicator, single-use

• Primary Device ID: 00868648000000
• NIH Device Record Key: 1d571f8c-fa21-4b09-8e75-dc760d90f789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sephure® suppository applicator
• Version Model Number: A2-30
• Company DUNS: 080739421
• Company Name: Cristcot LLC
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com
• Phone: 978-212-6380
• Email: info@sephure.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850325006405 [Primary]
GS1	00868648000000 [Unit of Use]
GS1	00868648000031 [Primary]
GS1	00868648000055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092829

FDA Product Code

• OOW: Applicator For Rectal Suppository

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-06
• Device Publish Date: 2021-09-28

On-Brand Devices [Sephure® suppository applicator]

• 00868648000000: A2 30-pouch - rectal suppository applicator, USA
• 00868648000017: B3 - rectal suppository applicator (individually wrapped)
• 00850325006320: size 0 capsule suppository applicator, 6 total