Locking Syringe LSS-100

GUDID 10813079020018

10cc

REMINGTON MEDICAL, INC.

General-purpose syringe, single-use

• Primary Device ID: 10813079020018
• NIH Device Record Key: 5639ad4f-7b40-4828-ac8e-ed17cdc75719
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Syringe
• Version Model Number: LSS-100
• Catalog Number: LSS-100
• Company DUNS: 788472314
• Company Name: REMINGTON MEDICAL, INC.
• Device Count: 1
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079020011 [Primary]
GS1	10813079020018 [Package]; Contains: 00813079020011; Package: Inner Carton [25 Units]; In Commercial Distribution
GS1	20813079020015 [Package]; Package: Shipping Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943651

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[10813079020018]

Ethylene Oxide

[10813079020018]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2016-09-21

Devices Manufactured by REMINGTON MEDICAL, INC.

• 10813079022616 - VascuChek Surgical Probe: 2024-09-02 Surgical Probe (sterile) used with transceiver
• 00813079022626 - VascuChek Transceiver: 2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow.
• 00813079022633 - VascuChek Charger: 2024-09-02 Replacement Charger used with the transceiver
• 00813079022640 - VascuChek Kit: 2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
• 10813079022654 - VascuChek Clinical Probe: 2024-09-02 Clinical Probe (non-sterile) used with transceiver.
• 10813079020223 - Bone Marrow "I" Needle: 2020-10-02 15ga (1.8mm) x 1 7/8" (5cm)
• 20813079020237 - Bone Marrow "I" Needle: 2020-10-02 16ga (1.7mm) x 1 7/8" (5cm)
• 10813079020247 - Bone Marrow "J" Needle Double Diamond Tip: 2020-10-02 11ga (3.0mm) x 4in. (10cm)