FDA UDI
In Commercial Distribution
🇺🇸 United States
Special Plus model gown (length 130 cm) size XXL
DI: 08052141310427
·
Model: 22.D2174.00
·
OMNIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Special Plus model gown (length 130 cm) size XXL
- Primary DI
- 08052141310427
- Version / Model
- 22.D2174.00
- Company Name
- OMNIA SRL
- Labeler DUNS
- 447696675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-06-22
- Public Version
- 1
- Public Version Date
- 2023-06-30
- Public Version Status
- New
- Public Device Record Key
- 97a3ce09-723b-4124-a6be-85cc3871e4df
Device Description
Special Plus model gown (length 130 cm) size XXL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEA | Non-Surgical Isolation Gown | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35091 | Surgical gown, single-use | 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 single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08052141310410 | GS1 | ||||
| Primary | 08052141310427 | GS1 |