PECA®2.0 ACC1023P0002

GUDID 03700879517957

Lid

NOVASTEP

Device sterilization/disinfection container, reusable

• Primary Device ID: 03700879517957
• NIH Device Record Key: fba6b635-823f-455a-8a63-b041513fe1d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PECA®2.0
• Version Model Number: ACC1023P0002
• Catalog Number: ACC1023P0002
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +33299338650
• Email: contact-intFA@enovis.com
• Phone: +33299338650
• Email: contact-intFA@enovis.com
• Phone: +33299338650
• Email: contact-intFA@enovis.com
• Phone: +33299338650
• Email: contact-intFA@enovis.com
• Phone: +33299338650
• Email: contact-intFA@enovis.com
• Phone: +33299338650
• Email: contact-intFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com
• Phone: +33299338650
• Email: regulatory-IntFA@enovis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879517957 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

[03700879517957]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-21
• Device Publish Date: 2025-11-13

On-Brand Devices [PECA®2.0]

• 03700879516233: Bunion implant Ø4 lg30
• 03700879517957: Lid
• 03700879517940: Tray
• 03700879515335: Beveled compressive implant Ø4 lg60
• 03700879515328: Beveled compressive implant Ø4 lg55
• 03700879515311: Beveled compressive implant Ø4 lg50
• 03700879515304: Beveled compressive implant Ø4 lg48
• 03700879515298: Beveled compressive implant Ø4 lg46
• 03700879515281: Beveled compressive implant Ø4 lg44
• 03700879515274: Beveled compressive implant Ø4 lg42
• 03700879515267: Beveled compressive implant Ø4 lg40
• 03700879515250: Beveled compressive implant Ø4 lg38
• 03700879515243: Beveled compressive implant Ø4 lg36
• 03700879515236: Beveled compressive implant Ø4 lg34
• 03700879515229: Beveled compressive implant Ø4 lg32
• 03700879515212: Beveled compressive implant Ø4 lg30
• 03700879515205: Beveled compressive implant Ø4 lg28
• 03700879515199: Beveled compressive implant Ø4 lg26
• 03700879515182: Beveled compressive implant Ø4 lg24
• 03700879515175: Beveled compressive implant Ø4 lg22
• 03700879515168: Beveled compressive implant Ø4 lg20
• 03700879515151: Beveled compressive implant Ø4 lg18