Integra® Ruggles®-Redmond™ RB4834

GUDID M274RB48341

STEALTH MICRO KERRISON RONGEUR

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Spinal rongeur

• Primary Device ID: M274RB48341
• NIH Device Record Key: 6f4b040e-a7aa-4ddb-8d56-dc8bd498cb47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Ruggles®-Redmond™
• Version Model Number: RB4834
• Catalog Number: RB4834
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Device Count: 1
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780137757 [Primary]
HIBCC	M274RB48341 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150428

FDA Product Code

• HAE: RONGEUR, MANUAL

Sterilization

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

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

[M274RB48341]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-08-14

On-Brand Devices [Integra® Ruggles®-Redmond™]

• M274RE08301: Spinal Curette, 8", Angled, Size 6
• M274RE08281: Spinal Curette, 8", Angled, Size 4
• M274RN08991: Micro Curette, 9", Bayonet, Reverse Angled, Size 3-0
• M274RN08981: Micro Curette, 9", Bayonet, Reverse Angled, Size 4-0
• M274RN08971: Micro Curette, 9", Bayonet, Reverse Angled, Size 5-0
• M274RN08881: Micro Curette, 9", Bayonet, Angled, Size 3-0
• M274RN08871: Micro Curette, 9", Bayonet, Angled, Size 4-0
• M274RN08861: Micro Curette, 9", Bayonet, Angled, Size 5-0
• M274RN08831: Micro Curette, 9", Bayonet, Straight, Size 3-0
• M274RN08821: Micro Curette, 9", Bayonet, Straight, Size 4-0
• M274RN08811: Micro Curette, 9", Bayonet, Straight, Size 5-0
• M274RN08221: Epstein Curette, 7-3/4", Reverse Angled, Size 0
• M274RN08211: Epstein Curette, 7-3/4", Reverse Angled, Size 2-0
• M274RN06051: Spinal Curette, 6-3/4", Straight, Size 2
• M274RN06041: Spinal Curette, 6-3/4", Straight, Size 1
• M274RN06021: Spinal Curette, 6-3/4", Straight, Size 2-0
• M274RN012081: Spinal Curette, 11-3/4", Straight, Size 4
• M274RN012071: Spinal Curette, 11-3/4", Straight, Size 3
• M274RN012061: Spinal Curette, 11-3/4", Straight, Size 2
• M274RN012051: Spinal Curette, 11-3/4", Straight, Size 1
• M274RB78161: Spinal Curette, 9", Ultra-Coat, Reverse Angled, Size 0
• M274RB78151: Spinal Curette, 9", Ultra-Coat, Reverse Angled, Size 2-0
• M274RB78141: Spinal Curette, 9", Ultra-Coat, Reverse Angled, Size 3-0
• M274RB78121: Spinal Curette, 9", Ultra-Coat, Reverse Angled, Size 5-0
• M274RB78041: Spinal Curette, 7-3/4", Ultra-Coat, Reverse Angled, Size 2-0
• M274RB78031: Spinal Curette, 7-3/4", Ultra-Coat, Reverse Angled, Size 3-0
• M274RB78021: Spinal Curette, 7-3/4", Ultra-Coat, Reverse Angled, Size 4-0
• M274RB78011: Spinal Curette, 7-3/4", Ultra-Coat, Reverse Angled, Size 5-0
• M274RB77601: Spinal Curette, 9", Ultra-Coat, Angled, Size 0
• M274RB77591: Spinal Curette, 9", Ultra-Coat, Angled, Size 2-0
• M274RB77581: Spinal Curette, 9", Ultra-Coat, Angled, Size 3-0
• M274RB77561: Spinal Curette, 9", Ultra-Coat, Angled, Size 5-0
• M274RB77521: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 3
• M274RB77511: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 2
• M274RB77501: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 1
• M274RB77481: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 2-0
• M274RB77471: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 3-0
• M274RB77461: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 4-0
• M274RB77451: Spinal Curette, 7-3/4", Ultra-Coat, Angled, Size 5-0
• M274RB77271: Spinal Curette, 9", Ultra-Coat, Straight, Size 0
• M274RB77261: Spinal Curette, 9", Ultra-Coat, Straight, Size 2-0
• M274RB77251: Spinal Curette, 9", Ultra-Coat, Straight, Size 3-0
• M274RB77231: Spinal Curette, 9", Ultra-Coat, Straight, Size 5-0
• M274RB77151: Spinal Curette, 7-3/4", Ultra-Coat, Straight, Size 2-0
• M274RB77141: Spinal Curette, 7-3/4", Ultra-Coat, Straight, Size 3-0
• M274RB77131: Spinal Curette, 7-3/4", Ultra-Coat, Straight, Size 4-0
• M274RB77121: Spinal Curette, 7-3/4", Ultra-Coat, Straight, Size 5-0
• M274RR82291: Bone Cutter Curette, 9-1/2", Extra Large, Cervical, Bayonet, Backward Angle
• M274RR82281: Curette, 9-1/2", Extra Large, Cervical, Bayonet, Backward Angle, Size 4-0
• M274RR82271: Curette, 9-1/2", Extra Large, Cervical, Bayonet, Backward Angle, Size 3-0