Needle Holder Self Righting Short

GUDID B3543529

Needle Holder Self Righting Short

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B3543529
• NIH Device Record Key: ba5160ea-0794-46d7-9a5c-1227f69151b5
• Commercial Distribution Discontinuation: 2023-07-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Needle Holder Self Righting Short
• Version Model Number: C352
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 9999
• 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: false
• Lot Batch: false
• Serial Number: true
• 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
HIBCC	B3543529 [Unit of Use]
HIBCC	B354C3529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

[B3543529]

Peracetic Acid

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-17
• Device Publish Date: 2023-07-07

On-Brand Devices [Needle Holder Self Righting Short]

• B3543529: Needle Holder Self Righting Short
• B3543525: Needle Holder Self Righting Short
• B3543524: Needle Holder Self Righting Short
• B3543523: Needle Holder Self Righting Short
• B3543522: Needle Holder Self Righting Short
• B3543521: Needle Holder Self Righting Short
• B354C3520: Needle Holder Self Righting Short
• B3543519: Needle Holder Self Righting Short
• B3543515: Needle Holder Self Righting Short
• B3543514: Needle Holder Self Righting Short
• B3543513: Needle Holder Self Righting Short
• B3543512: Needle Holder Self Righting Short
• B3543511: Needle Holder Self Righting Short
• B354C3510: Needle Holder Self Righting Short