FDA UDI
In Commercial Distribution
🇺🇸 United States
Jet-Vac Safety Procedure Tray
DI: 00813623012318
·
Model: M7553
·
PFM MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Jet-Vac Safety Procedure Tray
- Primary DI
- 00813623012318
- Version / Model
- M7553
- Catalog Number
- M7553
- Company Name
- PFM MEDICAL INCORPORATED
- Labeler DUNS
- 097736867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-02
- Public Version
- 4
- Public Version Date
- 2019-09-06
- Public Version Status
- Update
- Public Device Record Key
- 55ebb7b9-8a17-40ad-b7c2-fa98476c458a
Device Description
5F x 7cm Jet-Vac Safety Procedure Tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GCB | Needle, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36142 | Aspiration tray, single-use | A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813623012315 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00813623012318 | GS1 |
Customer Contacts
- Phone
- 7607588749
- [email protected]