FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterimed
DI: 00850341007226
·
Model: 4065
·
STERIMED LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Sterimed
- Primary DI
- 00850341007226
- Version / Model
- 4065
- Company Name
- STERIMED LLC
- Labeler DUNS
- 080284658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- a7235143-c382-46a9-94b6-9f45dbe5e9d8
Device Description
Equipment Drape 40" X 65"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZI | System, X-Ray, Angiographic | Radiology | 892.1600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43071 | X-ray system cover | A sterile piece of material used to cover an x-ray system during a surgical procedure to create a sterile barrier between the sterile operating field and the x-ray system, or the prominent parts of the x-ray system that intrude the sterile field. Since x-ray systems cannot be sterilized, this device is draped over/attached to the x-ray system allowing its use without compromising the sterile field. It will also protect the x-ray system from patient contaminants. It is available in a variety of shapes and sizes. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850341007220 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 10850341007223 | GS1 | Inner Pack/Box | 100 | In Commercial Distribution | |
| Primary | 00850341007226 | GS1 |
Customer Contacts
- Phone
- 770-387-0771
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K853044 | 000 |