← Back to catalogue

DOFF n DONNER ROLLY

FDA UDI

Class I (US FDA UDI)

by Sigvaris, Inc.

Identity

Trade Name
DOFF n DONNER ROLLY FDA UDI
Generic Name
Assistive sock/pantyhose dressing device FDA UDI
Device Name
A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). FDA UDI
Model / Reference
358496 FDA UDI
Description
A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). FDA UDI

Identifiers

Catalog Number
358496 FDA UDI
Primary DI / UDI-DI
07613378302572 FDA UDI
FDA Product Code
IKX FDA UDI
GMDN Term
Assistive sock/pantyhose dressing device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Category: Assistive sock/pantyhose dressing device

DOFF n DONNER ROLLY by Sigvaris, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assistive sock/pantyhose dressing device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sigvaris, Inc.

Sources (1)

  • FDA UDI 7ab25863-5588-4e6a-8cb8-fb0b41a2cf7c 36 fields · synced Jun 8, 2026