FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnia Medical PsiF 90
DI: 00843511127749
·
Model: 22-7P-P901
·
OMNIA MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Omnia Medical PsiF 90
- Primary DI
- 00843511127749
- Version / Model
- 22-7P-P901
- Company Name
- OMNIA MEDICAL, LLC
- Labeler DUNS
- 079467378
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-12
- Public Version
- 1
- Public Version Date
- 2024-06-20
- Public Version Status
- New
- Public Device Record Key
- d74420f6-7416-401d-8d8c-85fbacbcfa44
Device Description
PsiF 90 Surgery Ready Tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65161 | Instrument tray, single-use | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure. It is in the form of a shallow receptacle with a raised rim and moulded positions for placing the instruments. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843511127749 | GS1 |
Customer Contacts
- Phone
- 3044134851
- [email protected]