FDA UDI
In Commercial Distribution
🇺🇸 United States
NATIONAL HOSPITAL PACKAGING
DI: 00817213020738
·
Model: 16-002
·
Surgi-Pak, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NATIONAL HOSPITAL PACKAGING
- Primary DI
- 00817213020738
- Version / Model
- 16-002
- Catalog Number
- 16-002
- Company Name
- Surgi-Pak, Inc.
- Labeler DUNS
- 152736971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 2
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- 6696b3e6-31ba-424a-a3e0-3f22813f036d
Device Description
COTTON BALLS, MEDIUM, 2/PKG, STRL
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63281 | Cotton wool ball | A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817213021988 | GS1 | Case | 96 | In Commercial Distribution | |
| Primary | 00817213020738 | GS1 |
Customer Contacts
- Phone
- 6269683335
- [email protected]