FDA UDI
In Commercial Distribution
🇺🇸 United States
NATIONAL HOSPITAL PACKAGING
DI: 00817213021162
·
Model: 26-002R
·
Surgi-Pak, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NATIONAL HOSPITAL PACKAGING
- Primary DI
- 00817213021162
- Version / Model
- 26-002R
- Catalog Number
- 26-002R
- Company Name
- Surgi-Pak, Inc.
- Labeler DUNS
- 152736971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 2
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- f194aafe-1f53-4fd2-9669-602a6fd4f45f
Device Description
COMBINE PAD, 12IN X 16IN, 1/PKG, X-RAY DETECTABLE, 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 |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48131 | Non-woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817213022329 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00817213021162 | GS1 |
Customer Contacts
- Phone
- 6269683335
- [email protected]