Identity
- Trade Name
- MSI Precision Specialty Instruments FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- Surgical Skin Marker, Ultra Fine Tip, Ruler, 100 Per Box FDA UDI
- Model / Reference
- 1436SR-100 FDA UDI
- Description
- Surgical Skin Marker, Ultra Fine Tip, Ruler, 100 Per Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194613123260 FDA UDI
- FDA Product Code
- FZZ FDA UDI
- GMDN Term
- Skin marking pen, single-use 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Skin marking pen, single-use
MSI Precision Specialty Instruments by Med Saver, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin marking pen, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- WriteSite® Jr. Small Preoperative Skin Marker — Aspen Surgical Products, Inc. · Class I
- NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box) — XODUS MEDICAL, INC. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- NSMKR7132 Dual Tip Skin Marker Gentian Reg & Fine Tip -PL — XODUS MEDICAL, INC. · Class I
- Richard-Allan® Utility Marker with Labels — Aspen Surgical Products, Inc. · Class I
- Richard-Allan® Fine Tip Utility Pen — Aspen Surgical Products, Inc. · Class I
- Bioseal Inc. — BIOSEAL · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Med Saver, Inc.
Sources (1)
- FDA UDI 23378e57-43d4-48bd-99c9-f191ce586b02 34 fields · synced May 30, 2026