3 Ring suture kit with 5mm and 10 mm swab

GUDID B35430

3 Ring suture kit with 5mm and 10 mm swab

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B35430
• NIH Device Record Key: 34a986c3-79bb-42f5-962c-1dfb09ee11af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Ring suture kit with 5mm and 10 mm swab
• Version Model Number: B354OS3CDKS
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 99999
• 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	B35430 [Unit of Use]
HIBCC	B354OS3CDBK1 [Primary]
HIBCC	B354OS3CDBK2 [Primary]
HIBCC	B354OS3CDBK3 [Primary]
HIBCC	B354OS3CDBK4 [Primary]
HIBCC	B354OS3CDBK5 [Primary]
HIBCC	B354OS3CDBKS1 [Primary]
HIBCC	B354OS3CDK1 [Primary]
HIBCC	B354OS3CDK2 [Primary]
HIBCC	B354OS3CDK3 [Primary]
HIBCC	B354OS3CDK4 [Primary]
HIBCC	B354OS3CDK5 [Primary]
HIBCC	B354OS3CDK9 [Primary]
HIBCC	B354OS3CDKS1 [Primary]
HIBCC	B354OS3CDKS2 [Primary]
HIBCC	B354OS3CDKS3 [Primary]
HIBCC	B354OS3CDKS4 [Primary]
HIBCC	B354OS3CDKS5 [Primary]
HIBCC	B354OS3CDKS9 [Primary]
HIBCC	B354OSAPGD2 [Primary]
HIBCC	B354OSAPGD3 [Primary]
HIBCC	B354OSAPGD4 [Primary]
HIBCC	B354OSAPGD5 [Primary]
HIBCC	B354OSAPGD9 [Primary]
HIBCC	B354OSBC1 [Primary]
HIBCC	B354OSBC2 [Primary]
HIBCC	B354OSBC3 [Primary]
HIBCC	B354OSBC4 [Primary]
HIBCC	B354OSBC5 [Primary]
HIBCC	B354OSBC9 [Primary]
HIBCC	B354OSC60001 [Primary]
HIBCC	B354OSC60002 [Primary]
HIBCC	B354OSC60003 [Primary]
HIBCC	B354OSC60004 [Primary]
HIBCC	B354OSC60005 [Primary]
HIBCC	B354OSC60009 [Primary]
HIBCC	B354OSC6000R1 [Primary]
HIBCC	B354OSC6000R2 [Primary]
HIBCC	B354OSC6000R3 [Primary]
HIBCC	B354OSC6000R4 [Primary]
HIBCC	B354OSC6000R5 [Primary]
HIBCC	B354OSC6000R9 [Primary]
HIBCC	B354OSCFRLG21 [Primary]
HIBCC	B354OSCFRLG22 [Primary]
HIBCC	B354OSCFRLG23 [Primary]
HIBCC	B354OSCFRLG24 [Primary]
HIBCC	B354OSCFRLG25 [Primary]
HIBCC	B354OSCFRLG29 [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

[B35430]

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Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

Peracetic Acid

[B35430]

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

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