FDA UDI
In Commercial Distribution
🇺🇸 United States
Sigma Swab
DI: 05060259070402
·
Model: N/a
·
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Sigma Swab
- Primary DI
- 05060259070402
- Version / Model
- N/a
- Catalog Number
- MW941
- Company Name
- MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
- Labeler DUNS
- 216096750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 1
- Public Version Date
- 2023-10-13
- Public Version Status
- New
- Public Device Record Key
- 7dbf95ea-51a0-4644-8e06-b252b7e9b4c0
Device Description
Sigma swab - polyurethane
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 45060259070400 | GS1 | Box | 2000 | In Commercial Distribution | |
| Primary | 05060259070402 | GS1 | ||||
| Unit of Use | 35060259070403 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius