← Back to catalogue

Scanlan® PrepMARK

FDA UDI

Class I (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name
Scanlan® PrepMARK FDA UDI
Generic Name
Skin marking pen, single-use, non-sterile FDA UDI
Device Name
Scanlan® PrepMARK - Reg Tip, Gentian Violet, Non-Sterile, Box 50 FDA UDI
Model / Reference
1001-731 FDA UDI
Description
Scanlan® PrepMARK - Reg Tip, Gentian Violet, Non-Sterile, Box 50 FDA UDI

Identifiers

Catalog Number
1001-731 FDA UDI
Primary DI / UDI-DI
00846159025392 FDA UDI
FDA Product Code
FZZ FDA UDI
GMDN Term
Skin marking pen, single-use, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4660 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Skin marking pen, single-use, non-sterile

Scanlan® PrepMARK by Scanlan International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin marking pen, single-use, non-sterile.

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
Scanlan International Inc

Sources (1)

  • FDA UDI 4f6e4eee-0b48-4c5d-a563-a91d016548be 35 fields · synced Jun 8, 2026