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pma Primary ID: N970012

AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS (UDI N970012)

Manufactured by Boston Scientific Corp

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS - Primary ID N970012

Device Regulatory Overview

The AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS (Model/Catalog Number: Unspecified) is a medical device manufactured by Boston Scientific Corp. This product is indexed under FDA Product Code / Category Classification FHW within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0464-2016 View Full Alert →

IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The Intell...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0465-2016 View Full Alert →

IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The Int...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0462-2016 View Full Alert →

IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: Th...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Product Code / EMDN
FHW
Device Name
Device, impotence, mechanical/hydraulic
Database Sync Date
2026-08-09 10:04:44

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS?

The registered manufacturer of record for AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS is Boston Scientific Corp.

What is the Primary UDI-DI identifier for AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is N970012.

What classification code is assigned to this device?

This device is registered under product classification code FHW.

Similar Classification Devices (FHW)

Other Devices by Boston Scientific Corp

Programmatic Export

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