FDA UDI
In Commercial Distribution
🇺🇸 United States
Promax Surgical Gown
DI: 00634916825367
·
Model: 75675215
·
STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- Promax Surgical Gown
- Primary DI
- 00634916825367
- Version / Model
- 75675215
- Company Name
- STANDARD TEXTILE CO., INC.
- Labeler DUNS
- 006999858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2021-12-10
- Public Version
- 1
- Public Version Date
- 2021-12-22
- Public Version Status
- New
- Public Device Record Key
- 6c503e18-a062-4344-8032-2e38b72e1ee2
Device Description
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size Large
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
- No
- 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 |
|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11902 | Surgical gown, reusable | A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment intended to be laundered after each use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10634916825364 | GS1 | ||||
| Primary | 00634916825367 | GS1 |
Customer Contacts
- Phone
- 1-800-999-0400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041540 | 000 |