FDA UDI
In Commercial Distribution
🇺🇸 United States
ProTector
DI: H816MPNS5001
·
Model: PNS500
·
MicroCare, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
500
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Basic Information
- Brand Name
- ProTector
- Primary DI
- H816MPNS5001
- Version / Model
- PNS500
- Catalog Number
- PNS500-1
- Company Name
- MicroCare, LLC
- Labeler DUNS
- 118518186
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-10-26
- Public Version
- 3
- Public Version Date
- 2023-09-20
- Public Version Status
- Update
- Public Device Record Key
- 68fc959f-01d8-42b4-a95f-7fb86837de65
Device Description
Needle Sheath Prop
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12236 | Surgical instrument interim-placement holder, single-use | A device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H816MPNS5002 | HIBCC | Case Box | 6 | In Commercial Distribution | |
| Primary | H816MPNS5001 | HIBCC | ||||
| Unit of Use | H816MPNS5000 | HIBCC | ||||
| Previous | H816PNS5001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052725 | 000 |