FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiClear 4x13
DI: 00825439010273
·
Model: TWBD1018
·
Covalon Technologies Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SurgiClear 4x13
- Primary DI
- 00825439010273
- Version / Model
- TWBD1018
- Company Name
- Covalon Technologies Ltd
- Labeler DUNS
- 206936101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 1
- Public Version Date
- 2022-12-09
- Public Version Status
- New
- Public Device Record Key
- 0cc3ec3c-7970-46de-8464-79321994cd59
Device Description
Antimicrobial clear silicone adhesive dressing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58302 | Antimicrobial synthetic polymer semi-permeable film dressing, adhesive | A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent. It is a thin, clear film made of synthetic polymer with a pressure-sensitive adhesive on one side that may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions, ulcers, burns, lacerations, abrasions, device insertion sites, and donor/graft sites. It may also be used to secure to skin other devices (e.g., catheters, drains, leads, ports). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00825439010280 | GS1 | Carton | 25 | In Commercial Distribution | |
| Primary | 00825439010273 | GS1 | ||||
| Package | 10825439010287 | GS1 | Shipper | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121819 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 13 | Centimeter | |
| Width | 4 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius