HITACHI

GUDID 04562122957809

Needle guide

HITACHI, LTD.

Nonimplantable needle guide, reusable

• Primary Device ID: 04562122957809
• NIH Device Record Key: c4c42620-81de-49c8-8bad-4a960e6bce69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HITACHI
• Version Model Number: MP-2785-G22
• Company DUNS: 693002605
• Company Name: HITACHI, LTD.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	04562122957809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122537

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

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

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

[04562122957809]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-09-24

On-Brand Devices [HITACHI]

• 04580292776150: ETG-4000
• 04580292775009: Probe
• 04580292774996: Probe
• 04580292774989: Probe
• 04580292774972: Probe
• 04580292774965: Probe
• 04580292774958: Probe
• 04580292774941: Probe
• 04580292774934: Probe
• 04580292774927: Probe
• 04580292774910: Probe
• 04580292774903: Probe
• 04580292774897: Probe
• 04580292774880: Probe
• 04580292774873: Probe
• 04580292774866: Probe
• 04580292774859: Probe
• 04580292774842: Probe
• 04580292774835: Probe
• 04580292774811: Probe
• 04580292774538: Probe
• 04580292774521: Probe
• 04580292774514: Probe
• 04580292774507: Probe
• 04580292774491: Probe
• 04580292774422: Probe
• 04580292774415: Probe
• 04580292774408: Probe
• 04580292774392: Probe
• 04580292774194: Needle Guide Bracket
• 04580292774187: Needle Guide Bracket
• 04580292774040: Biopsy Attachment
• 04580292774033: Biopsy Attachment
• 04580292774026: Biopsy Attachment
• 04580292773982: Puncture Guide Fixture
• 04580292773791: Probe
• 04580292773784: Probe
• 04580292773777: Probe
• 04580292773739: Probe
• 04580292773722: Probe
• 04580292773715: Probe
• 04580292773678: Probe
• 04580292773661: Probe
• 04580292773647: Needle Guide Bracket
• 04580292773616: Probe
• 04580292773609: Probe
• 04580292773593: Probe
• 04580292773562: Probe
• 04580292773531: Probe
• 04580292773524: Probe