Sinton Medical Products HS-SK002

GUDID 06938327900250

Small spike

Shenzhen Boon Medical Supply Co., Ltd.

Angiographic catheter, single-use

• Primary Device ID: 06938327900250
• NIH Device Record Key: c5581ca1-e675-4d95-87dd-b30e63cf8f62
• Commercial Distribution Discontinuation: 2020-04-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sinton Medical Products
• Version Model Number: 700102
• Catalog Number: HS-SK002
• Company DUNS: 529174252
• Company Name: Shenzhen Boon Medical Supply Co., Ltd.
• 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: true
• 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(954)380-8873
• Email: sales@sintonmedicalproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327900250 [Primary]
GS1	16938327900250 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	16938327900257 [Package]; Package: Box [50 Units]; Discontinued: 2020-04-27; Not in Commercial Distribution
GS1	26938327900250 [Package]; Contains: 16938327900250; Package: Carton [2 Units]; In Commercial Distribution
GS1	26938327900254 [Package]; Contains: 16938327900257; Package: Carton [2 Units]; Discontinued: 2020-04-27; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151960

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-04-28
• Device Publish Date: 2016-12-09

On-Brand Devices [Sinton Medical Products]

• 26938327902876: 1-21" Transfer Set with Swabable Valve and Ball Check Valve Spike
• 26938327902869: 1-21" Transfer Set with Swabable Valve
• 26938327902852: 1-21" Transfer Set with C Clamp
• 26938327902845: 1-9" Transfer Set with C Clamp
• 26938327902838: 1-Fill Straw
• 26938327902821: 1-Small Spike
• 26938327902814: 1-Large Spike
• 26938327902807: 1- 96"(2500mm) Y Tubing with Dual Check Valves
• 26938327902791: 1- 96"(2500mm) Y Coiled Tubing with Dual Check Valves
• 26938327902784: 1- 96"(2500mm) T Tubing with Check Valve
• 26938327902777: 1- 96"(2500mm) T Coiled Tubing with Check Valve
• 26938327902760: 1-96"(2500mm) Straight Tubing with Dual Check Valves
• 26938327902753: 1-72"(1800mm) Straight Tubing with Dual Check Valves
• 26938327902746: 1-60"(1500mm) Straight Tubing with Dual Check Valves
• 26938327902739: 1- 72"(1800mm) T Coiled Tubing with Check Valve
• 26938327902722: 1- 72"(1800mm) T Tubing with Check Valve
• 26938327902715: 1- 60"(1500mm) T Tubing with Check Valve
• 26938327902708: 1- 60"(1500mm) T Coiled Tubing with Check Valve
• 26938327902692: 1- 72"(1800mm) Y Coiled Tubing with Dual Check Valves
• 26938327902685: 1- 72"(1800mm) Y Tubing with Dual Check Valves
• 26938327902678: 1- 72"(1800mm) Y Coiled Tubing with Check Valve
• 26938327902661: 1- 72"(1800mm) Y Tubing with Check Valve
• 26938327902654: 1-200mm Y Tubing with Dual Check Valves
• 26938327902647: 1- 60"(1500mm) Y Tubing with Dual Check Valves
• 26938327902630: 1- 60"(1500mm) Y Coiled Tubing with Check Valve
• 26938327902623: 1- 60"(1500mm) Y Tubing with Check Valve
• 26938327902616: 1- 60"(1500mm) Y Coiled Tubing with Dual Check Valves
• 26938327902609: 1- 96"(2500mm) Straight Tubing with Check Valve
• 26938327902593: 1-80" (2000mm) Coiled Tubing with Check Valve
• 26938327902586: 1-72" (1800mm) Coiled Tubing
• 26938327902579: 1-8" (200mm) Straight Tubing with Check Valve and Rotating Luer
• 26938327902562: 1-8" (200mm) Straight Tubing with Check Valve
• 26938327902555: 1-72" (1800mm) Coiled Tubing with Check Valve
• 26938327902548: 1-72"(1800mm) Straight Tubing with Check Valve
• 26938327902531: 1-60"(1500mm) Coiled Tubing with Check Valve
• 26938327902524: 1-60"(1500mm) Straight Tubing with Check Valve
• 26938327902517: 1-60"(1500mm) Straight Tubing
• 26938327902500: 1-60" (1500mm) Coiled Tubing
• 06938327902353: 1-100ml Syringe
• 26938327902340: 1-60 mL & 1-100 ml Syringes 2-Lar
• 26938327902333: 1-60 mL & 1-100 ml Syringes 2-Lar
• 26938327902326: 1-60 mL & 1-100 ml Syringes 2-Fil
• 26938327902319: 1-60 mL Syringe 1-Fill Straw
• 26938327902302: 2-60 mL Syringes 1-Large Spike & 1-Sm
• 26938327902296: 2-60 mL Syringes 1-Large Spike & 1-Sm
• 26938327902289: 2-100ml Syringes 2-Large Spikes & 2-F
• 26938327902272: 2-100ml Syringes 2-Large Spikes
• 26938327902265: 2-100ml Syringes 2-Fill Straws
• 26938327902258: 1-100ml Syringe 1-Large Spike & 1-Fill
• 26938327902241: 1-100ml Syringe 1-Large Spike