Identity
- Trade Name
- Sterile 3” Foam Swab with yellow handle V2 FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- Device Name
- single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares FDA UDI
- Model / Reference
- 60612 FDA UDI
- Description
- single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027193106 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: General-purpose absorbent tip applicator/swab, single-use
Sterile 3” Foam Swab with yellow handle V2 by Steripack Usa (limited) Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
- Disposable Collection Tubes of Virus Samples — Jiangsu Mole Bioscience Co., LTD. · Class A
- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
- Disposable sampling swab — Jiangsu HanHeng Medical Technology Co., Ltd. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · 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 |
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Manufacturer
- Manufacturer
- Steripack Usa (limited) Llc
Sources (1)
- FDA UDI 597b48f2-03ff-4ca8-878a-a1e201e1ca46 33 fields · synced May 30, 2026