Ethicon

GUDID B504OMPRW350

Provision

Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable Skin stapler/staple, non-bioabsorbable

• Primary Device ID: B504OMPRW350
• NIH Device Record Key: a1daf334-953a-4471-855f-dc5916f4e06f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethicon
• Version Model Number: PRW35
• Company DUNS: 016889401
• Company Name: Provision
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 541-480-7953
• Email: customersupport@provisiondrs.c
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.c
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B504OMPRW350 [Primary]

FDA Product Code

• GDT: Staple, Removable (Skin)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-29

On-Brand Devices [Ethicon]

• B504TRH12LP0: H12LP
• B504OMPXW350: PXW35
• B504OMPXR350: PXR35
• B504OMPRW350: PRW35
• B504OMPRR350: PRR35
• B504D5ST0: D5ST
• B504D5LT0: D5LT
• B504D12XT0: D12XT
• B504D12LT0: D12LT
• B504D11LT0: D11LT
• B504CB5ST0: CB5ST
• B504CB5LT0: CB5LT
• B504CB12LT0: CB12LT
• B504CB11LT0: CB11LT
• B504B8LT9: B8LT
• B504B8LT0: B8LT
• B504B5XT9: B5XT
• B504B5XT0: B5XT
• B504B5ST0: B5ST
• B504B5SP0: B5SP
• B504B5LT0: B5LT
• B504B5LPH0: B5LPH
• B504B5LP0: B5LP
• B504B15LT9: B15LT
• B504B15LT0: B15LT
• B504B12XT9: B12XT
• B504B12XT0: B12XT
• B504B12SRT0: B12SRT
• B504B12LTH0: B12LTH
• B504B12LT0: B12LT
• B504B12LPH0: B12LPH
• B504B12LP0: B12LP
• B504B11LTH0: B11LTH
• B504B11LT0: B11LT
• B504B11LPH0: B11LPH
• B504B11LP0: B11LP
• 08100410609076: H12LP
• 08100410609069: D5ST
• 08100410609052: D5LT
• 08100410609045: D12XT
• 08100410609038: D12LT
• 08100410609021: D11LT
• 08100410609014: CB5ST
• 08100410609007: CB5LT
• 08100410608994: CB12LT
• 08100410608987: CB11LT
• 08100410608970: B8LT
• 08100410608963: B5XT
• 08100410608956: B5ST
• 08100410608949: B5SP