FDA UDI
In Commercial Distribution
🇺🇸 United States
Safco One Sheet Tray Covers
DI: D72310261503
·
Model: 1026150
·
SAFCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Safco One Sheet Tray Covers
- Primary DI
- D72310261503
- Version / Model
- 1026150
- Catalog Number
- 1026150
- Company Name
- SAFCO DENTAL SUPPLY CO.
- Labeler DUNS
- 020417380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2022-12-12
- Public Version
- 1
- Public Version Date
- 2022-12-20
- Public Version Status
- New
- Public Device Record Key
- 9f2d7768-e032-460d-9806-1a6f3592ffb3
Device Description
Safco One Sheet tray covers, white, 1,000/box
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 |
|---|---|---|---|---|
| KHR | ABSORBER, SALIVA, PAPER | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64367 | Instrument tray cover, single-use | A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D72310261500 | HIBCC | ||||
| Primary | D72310261503 | HIBCC |