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Holter®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
HOLTER® FDA UDI
Generic Name
Subcutaneous tunneller, reusable FDA UDI
Device Name
Peritoneal Catheter Placement Instrument FDA UDI
Model / Reference
821693 FDA UDI
Description
Peritoneal Catheter Placement Instrument FDA UDI

Identifiers

Catalog Number
82-1693 FDA UDI
Primary DI / UDI-DI
10381780518068 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Subcutaneous tunneller, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Subcutaneous tunneller, reusable

Holter® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous tunneller, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 68dd5c8a-60e0-4958-92de-55af17c3e138 35 fields · synced Jun 9, 2026