AVID TruCustom

GUDID 20809160002855

AVID MEDICAL, INC.

Spinal needle, single-use

• Primary Device ID: 20809160002855
• NIH Device Record Key: b2da32bf-cfe9-43bf-bb1d-debbe7629b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVID TruCustom
• Version Model Number: RMCN2206_0007
• Company DUNS: 015623119
• Company Name: AVID MEDICAL, INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10809160002858 [Primary]
GS1	20809160002855 [Package]; Contains: 10809160002858; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971645

FDA Product Code

• MIA: NEEDLE, SPINAL, SHORT TERM

Sterilization

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

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

[20809160002855]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-15

On-Brand Devices [AVID TruCustom]

• 20809160232016: ROXS001-01_0004
• 20809160232009: AXOG7000-01_0007
• 20809160231996: ADVH067-17_0003
• 20809160231989: GRAN014-06_0001
• 20809160231972: LIFE0078-03_0006
• 20809160232085: NWHR011-01_0006
• 20809160232078: JNTH001-05_0007
• 20809160232061: GRAN014-06_0003
• 20809160232054: CMRL002-02_0001
• 20809160232047: CMRL001-02_0001
• 20809160232030: SMHS011-07_0002
• 20809160232023: ADVH067-17_0001
• 20809160232238: LIFP016-03_0002
• 20809160232221: LIFP004-11_0003
• 20809160232214: LIFP001-07_0002
• 20809160232207: HSAM006-12_0012
• 20809160232191: SINA251_0003
• 20809160232184: HSAM035-05_0013
• 20809160232177: BTMF015-03_0001
• 20809160232160: MAMC236-12_0008
• 20809160232153: RMRI021-25_0010
• 20809160232146: LANC034-18_0001
• 20809160232139: RMRI042-12_0003
• 20809160232122: KAFB006-11_0007
• 20809160232115: CMRL002-02_0004
• 20809160232269: PMHP005-02_0015
• 20809160232252: ADVC087-23_0002
• 20809160232535: NAFB079-01_0003
• 10809160232521: AVMD031_0014
• 20809160232290: SSSC002-03_0006
• 20809160232283: PMHP004-05_0002
• 20809160232627: NHRM002-01_0005
• 20809160232610: LIFP017-04_0002
• 20809160232603: CHWE016-02_0002
• 20809160232597: ADVM039-07_0003
• 20809160232580: CHWE001-02_0002
• 20809160232573: ADBR017-12_0003
• 20809160232566: ADVM022-19_0004
• 20809160233372: VAST038-02_0004
• 20809160233365: VAST031-03_0003
• 20809160233358: VANW025-03_0003
• 10809160233344: VANW011-04_0003
• 20809160233334: VAMH003-01_0003
• 10809160233320: VAHT026-10_0003
• 10809160233313: GVVA010-05_0003
• 10809160233306: GVVA004-06_0003
• 20809160233297: VAST026-08_0003
• 20809160233280: VAST018-07_0003
• 20809160233273: VAST017-06_0003
• 20809160233266: VAST016-07_0003