FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MediClear™ PreOp
DI: 00825439016169
·
Model: 7000830
·
Covalon Technologies Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- MediClear™ PreOp
- Primary DI
- 00825439016169
- Version / Model
- 7000830
- Company Name
- Covalon Technologies Ltd
- Labeler DUNS
- 206936101
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-18
- Public Version
- 7
- Public Version Date
- 2025-12-11
- Public Version Status
- Update
- Public Device Record Key
- 799b82d8-df50-4f7b-b95a-f36410e6b943
- Distribution End Date
- 2025-11-30
Device Description
Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Silver
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10825439016180 | GS1 | Shipper | 4 | Not in Commercial Distribution | 2025-11-30 |
| Package | 00825439016176 | GS1 | Carton | 25 | Not in Commercial Distribution | 2025-11-30 |
| Primary | 00825439016169 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8cm x 30cm (3in x 12in) |