FDA UDI
In Commercial Distribution
🇺🇸 United States
OR TOWEL ABS
DI: 00634916043136
·
Model: 48502BL5
·
STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
288
Basic Information
- Brand Name
- OR TOWEL ABS
- Primary DI
- 00634916043136
- Version / Model
- 48502BL5
- Catalog Number
- 48502BL5
- Company Name
- STANDARD TEXTILE CO., INC.
- Labeler DUNS
- 006999858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 288
- Record Status
- Published
- Publish Date
- 2018-01-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2d585210-9c37-48db-b298-edce631e62ae
Device Description
OR TOWEL ABS 18X33 KAUM MISTY RM (98 7042) USE: 48502322
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam 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 |
|---|---|---|---|---|---|---|
| Primary | 00634916043136 | GS1 | ||||
| Unit of Use | 10634916043136 | GS1 |
Customer Contacts
- Phone
- 1-800-999-0400
- [email protected]