Gold Anchor 0110

GUDID 07340145701114

Gold Anchor Introducer with 0.28x20 mm marker

Naslund Medical AB

Radiological image marker, implantable

• Primary Device ID: 07340145701114
• NIH Device Record Key: b1bc4c6b-249e-483c-bdc3-9aa16e62bc97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Anchor
• Version Model Number: GATD-20
• Catalog Number: 0110
• Company DUNS: 351991547
• Company Name: Naslund Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07340145701107 [Primary]
GS1	07340145701114 [Package]; Contains: 07340145701107; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213053

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-01-23

On-Brand Devices [Gold Anchor]

• 07340145700735: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x20 mm pre-loaded in (1) Fine Needle 22G 0.7x80
• 07340145700711: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 22G 0.7x80
• 07340145700629: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 20G 0.9x35
• 07340145700575: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x20 mm pre-loaded in (1) Fine Needle 22G 0.7x25
• 07340145700551: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 22G 0.7x25
• 07340145700490: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x20 mm pre-loaded in (1) Fine Needle 22G 0.7x15
• 07340145700476: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 22G 0.7x15
• 07340145700414: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x20 mm pre-loaded in (1) Fine Needle 20G 0.9x20
• 07340145700391: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 20G 0.9x20
• 07340145700377: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x20 mm pre-loaded in (1) Fine Needle 20G 0.9x20
• 07340145700353: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x10 mm pre-loaded in (1) Fine Needle 20G 0.9x20
• 07340145700339: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x20 mm pre-loaded in (1) Fine Needle 22G 0.7x20
• 07340145700315: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 22G 0.7x20
• 07340145700285: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x20 mm pre-loaded in (1) Fine Needle 22G 0.7x20
• 07340145700261: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x10 mm pre-loaded in (1) Fine Needle 22G 0.7x20
• 07340145700247: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x20 mm pre-loaded in (1) Fine Needle 25G 0.5x15
• 07340145700230: Fiducial Gold Marker. (1) Gold Anchor Marker 0.28x10 mm pre-loaded in (1) Fine Needle 25G 0.5x15
• 07340145700216: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x20 mm pre-loaded in (1) Fine Needle
• 07340145700193: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x10 mm pre-loaded in (1) Fine Needle
• 07340145700179: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x20 mm pre-loaded in (1) Fine Needle
• 07340145700155: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle
• 07340145700131: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x20 mm pre-loaded in (1) Fine Needle
• 07340145700100: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x10 mm pre-loaded in (1) Fine Needle
• 07340145700087: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x20 mm pre-loaded in (1) Fine Needle
• 07340145700063: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle
• 07340145700056: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x20 mm pre-loaded in (1) Fine Needle
• 07340145700032: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle
• 07340145701053: 20G (0.9mm) 20 cm needle with 0.28x10 mm marker
• 07340145701039: 25G (0.5mm) 15 cm needle with 0.28x20 mm marker
• 07340145701015: 25G (0.5mm) 15 cm needle with 0.28x10 mm marker
• 07340145700995: 22G (0.7mm) 25 cm needle with 0.40x20 mm marker
• 07340145700971: 22G (0.7mm) 25 cm needle with 0.40x10 mm marker
• 07340145700957: 22G (0.7mm) 20 cm needle with 0.40x20 mm marker
• 07340145700933: 22G (0.7mm) 20 cm needle with 0.40x10 mm marker
• 07340145700919: 22G (0.7mm) 20 cm needle with 0.28x20 mm marker
• 07340145700896: 22G (0.7mm) 20 cm needle with 0.28x10 mm marker
• 07340145700872: 22G (0.7mm) 15 cm needle with 0.40x20 mm marker
• 07340145700858: 22G (0.7mm) 15 cm needle with 0.40x10 mm marker
• 07340145700834: 22G (0.7mm) 8 cm needle with 0.40x20 mm marker
• 07340145700810: 22G (0.7mm) 8 cm needle with 0.40x10 mm marker
• 07340145700797: 20G (0.9mm) 35 cm needle with 0.40x10 mm marker
• 07340145700773: 20G (0.9mm) 20 cm needle with 0.40x20 mm marker
• 07340145700759: 20G (0.9mm) 20 cm needle with 0.40x10 mm marker
• 07340145701237: 20G (0.9mm) 10 cm needle with 0.40x20 mm marker
• 07340145701213: 20G (0.9mm) 10 cm needle with 0.40x10 mm marker
• 07340145701190: 20G (0.9mm) 10 cm needle with 0.40x20 mm marker
• 07340145701176: 20G (0.9mm) 10 cm needle with 0.40x10 mm marker
• 07340145701152: 22G (0.7mm) 8 cm needle with 0.28x10 mm marker
• 07340145701138: 22G (0.7mm) 15 cm needle with 0.28x10 mm marker
• 07340145701114: Gold Anchor Introducer with 0.28x20 mm marker