FibriJet

GUDID 10815634021782

FIBRIJET REGULATOR

MICROMEDICS, INC.

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• Primary Device ID: 10815634021782
• NIH Device Record Key: 4a54f799-6559-48eb-b065-010b25efd6ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FibriJet
• Version Model Number: SA-6030
• Company DUNS: 066839630
• Company Name: MICROMEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634021785 [Primary]
GS1	10815634021782 [Package]; Contains: 00815634021785; Package: Inner Pack [1 Units]; In Commercial Distribution

FDA Product Code

• CAN: Regulator, Pressure, Gas Cylinder

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: 2023-03-29
• Device Publish Date: 2023-03-21

On-Brand Devices [FibriJet]

• 20815634020508: 360° ENDOSCOPIC APPLICATOR WITH TETHER, 5MM x 40CM, 1:1 RATIO (US Indication)
• 00815634020368: Spray Set, Gas Assisted 360° Endoscopic Applicator Dual Cannula (40 cm)
• 10815634020327: Gas Assisted Applicator Kit, 11:1 Ratio
• 00815634020252: GAS ASSISTED APPLICATOR KIT
• 10815634020242: Topical, APPLICATOR TIP GAS ASSISTED Spray Set
• 00815634020238: 360° ENDOSCOPIC APPLICATOR, 35CM
• 00815634020221: Gas-Assisted SPRAY SET TOPICAL APPLICATOR WITH MIXING TIP
• 00815634020207: REPLACEMENT SPRAY TIPS (Tip Alignment Tool with 2 Spray Tips per pouch)
• 00815634020191: SPRAY SET ENDOSCOPIC APP. 5MMX40 CM, 11:1 RATIO
• 00815634020184: MANUAL ENDOSCOPIC SPRAY APP. W/MIX TIP 5MM X 40CM,11:1 RATIO
• 00815634020177: SPRAY SET ENDOSCOPIC APP. 5MMX30 CM, 11:1 RATIO
• 20815634020164: MANUAL ENDOSCOPIC SPRAY APP.W/MIX TIP 5MM X 20CM, 11:1 RATIO
• 00815634020153: APPLICATOR TIP DUAL LUMEN (Cannula) Endoscopic Semi-Flexible 5 MM X 32 cm (12.5 IN)
• 00815634020085: SPRAY SET ENDOSCOPIC APP. 5MM, 40 CM, 1:1 RATIO
• 10815634020075: GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
• 20815634020065: MANUAL ENDOSCOPIC SPRAY APP.W/MIX TIP 5MM X 30CM, 1:1 RATIO
• 00815634020986: Applicator Assembly, Ratio 11:1 w/ Dual Spray
• 10815634021133: APPLICATOR TIP, DUAL LUMEN (Cannula) Endoscopic Semi-Flexible 5 MM x 12.5'' (31.8)
• 10815634021348: Ratio Applicator Assembly, 11:1 Ratio
• 10815634021515: Magellan Spray Tip, Dual Spray
• 10815634021508: Cannula Tip, Dual Cannula, 20 ga x 7” (17.8cm)
• 10815634021492: Cannula Tip, Dual Cannula, 20 ga x 4” (10.2cm)
• 10815634021485: CANNULA TIP, DUAL CANNULA, 20 ga x 2.0”, BULK STERILE
• 10815634021478: CANNULA TIP, DUAL CANNULA, 20 ga. x 2” (5.1cm)
• 10815634021638: Single Channel Mixing Tip, Angled
• 10815634021614: Applicator Tip, Dual Cannula Malleable, 20ga. X 1.8” (4.6cm), Ratio 1:1
• 10815634021607: Applicator Tip, Dual Cannula Malleable, 20ga. X 7” (17.4cm), Ratio 1:1
• 10815634021591: Applicator Tip, Dual Cannula, Malleable, 20ga x 9.7cm, Ratio 1:1
• 10815634021584: Applicator Tip, Dual Cannula, 20 ga. X 10 1/4” (26cm)
• 10815634021577: Applicator Tip, Dual Cannula, 20 ga. X 7” (17.8cm)
• 10815634021560: Applicator Tip, Dual Cannula, 26 ga. X 3 1/4” (8.3cm)
• 10815634021553: Applicator Tip, Dual Cannula, 26 ga. X 2 1/4” (5.7cm)
• 10815634021546: Applicator Tip, Dual Cannula, 16 ga. X 4” (10.2cm)
• 10815634021522: MAGELLAN SPRAY TIP, DUAL SPRAY, BULK STERILE
• 10815634021706: Fibrijet Blending Connector with Spray Tip
• 10815634021690: Fibrijet Blending Connector With Single Cannula
• 10815634021683: Applicator Tip, Single Spray
• 10815634021676: Fibrijet Blending Connector
• 10815634021669: Single Cannula, Extended Applicator, 30cm
• 10815634021652: Single Cannula, Extended Applicator, 20cm
• 10815634021645: Single Cannula, Extended Applicator, 10cm
• 10815634021744: DUAL RATIO APPLICATOR KIT
• 10815634021737: Blending Connector with Mixer
• 10815634021720: Mixing Applicator Tip High Viscosity
• 10815634021713: Mixing Applicator Tip, Low Viscosity w/ Spray Tip
• 10815634021539: Applicator Assembly, 3cc Syringes, 1:1 Ratio
• 10815634021454: ARTHROSCOPIC DELIVERY KIT
• 10815634021232: Applicator Assembly, 5cc Syringes, Ratio 1:1
• 10815634021751: MIXING CONNECTOR WITH SPRAY TIP
• 10815634021423: APPLICATOR SPRAY TIP, MALLEABLE DUAL CANNULA, 20GAx10CM (4IN)