FDA UDI
In Commercial Distribution
🇺🇸 United States
Steri-Cel Pre-Cut Sheet
DI: 00843356101263
·
Model: SC4850
·
CYGNUS MEDICAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Steri-Cel Pre-Cut Sheet
- Primary DI
- 00843356101263
- Version / Model
- SC4850
- Company Name
- CYGNUS MEDICAL L.L.C.
- Labeler DUNS
- 103169095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 050dd946-a746-453a-af8c-ea77aacc4bb8
Device Description
Steri-Cel Pre-Cut Sheet 12 in. x 16 in. - 25 Sheets
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRP | Tray, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63247 | Surgical instrument guard, single-use | A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843356101260 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00843356101263 | GS1 | ||||
| Unit of Use | 30843356101264 | GS1 |