FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A Plus
DI: 00683534820506
·
Model: 1
·
A PLUS INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- A Plus
- Primary DI
- 00683534820506
- Version / Model
- 1
- Catalog Number
- 31319604
- Company Name
- A PLUS INTERNATIONAL INC.
- Labeler DUNS
- 191705904
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-19
- Public Version
- 2
- Public Version Date
- 2022-11-17
- Public Version Status
- Update
- Public Device Record Key
- 93d463e5-6343-418e-89d7-5b150c775112
- Distribution End Date
- 2022-11-16
Device Description
ORTTG-6004 STERL GREEN;O.R. TOWEL PW 4/PH, 80 Pc(s)/Case
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Radiation Sterilization"]
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 |
|---|---|---|---|---|
| 14077 | Surgical towel | A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 70683534820505 | GS1 | Inner Pack | 4 | Not in Commercial Distribution | 2022-11-16 |
| Primary | 00683534820506 | GS1 | ||||
| Package | 80683534820502 | GS1 | Case | 20 | Not in Commercial Distribution | 2022-11-16 |