FDA UDI
In Commercial Distribution
🇺🇸 United States
ECONOLUX GZ NS 4X4 12PLY 2000/CS 14,5tex
DI: 20612553015673
·
Model: 416817
·
HARTMANN USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- ECONOLUX GZ NS 4X4 12PLY 2000/CS 14,5tex
- Primary DI
- 20612553015673
- Version / Model
- 416817
- Company Name
- HARTMANN USA, INC.
- Labeler DUNS
- 010137511
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 2
- Public Version Date
- 2024-01-26
- Public Version Status
- Update
- Public Device Record Key
- bea8f51b-5d48-44fc-8eee-5fc4c6cc27c0
Device Description
ECONOLUX GZ NS 4X4 12PLY 2000/CS 14,5tex
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 48134 | Woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40612553015677 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 20612553015673 | GS1 | ||||
| Unit of Use | 10612553024500 | GS1 |