NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE FS+173230BC-G

GUDID 10383790000281

17Gx1-1/4" Fixed Hub 11" Tubing

NIPRO MEDICAL CORPORATION

Haemodialysis needle

• Primary Device ID: 10383790000281
• NIH Device Record Key: 56f21143-b4fc-4530-98a8-3b992802ff40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE
• Version Model Number: 17GX1-1/4
• Catalog Number: FS+173230BC-G
• Company DUNS: 797372554
• Company Name: NIPRO MEDICAL CORPORATION
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790000284 [Primary]
GS1	10383790000281 [Package]; Contains: 00383790000284; Package: Carton [50 Units]; In Commercial Distribution
GS1	40383790000282 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• FIE: Needle, fistula

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-20
• Device Publish Date: 2016-04-01

Devices Manufactured by NIPRO MEDICAL CORPORATION

• 10383790000304 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub
• 00383790000345 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub (twin pack)
• 10383790000366 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub
• 10383790000373 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, rotating hub
• 10383790000380 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, fixed hub
• 10383790000397 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, rotating hub
• 00383790000406 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub (twin pack)
• 10383790000427 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (16Gx1") 12" tube, fixed hub