FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGICAL STERILE DRAPE
DI: 08056646502202
·
Model: 12.T4332.00
·
OMNIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- SURGICAL STERILE DRAPE
- Primary DI
- 08056646502202
- Version / Model
- 12.T4332.00
- Company Name
- OMNIA SRL
- Labeler DUNS
- 447696675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-11
- Public Version
- 6
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 03a2119d-f588-489a-a981-672be781c1c0
Device Description
DRAPE CM 100X150 WITH ADHESIVE OFF CENTER HOLE CM 6X9 - ESSENTIAL LINE
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
- No
- 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 |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47783 | Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056646502202 | GS1 | ||||
| Unit of Use | 08056646502196 | GS1 |
Customer Contacts
- Phone
- +390524527453
- [email protected]