FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00858778006850
·
Model: PROBE-UMB
·
FOOTPRINT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 00858778006850
- Version / Model
- PROBE-UMB
- Company Name
- FOOTPRINT MEDICAL, INC.
- Labeler DUNS
- 791238046
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-28
- Public Version
- 1
- Public Version Date
- 2024-04-05
- Public Version Status
- New
- Public Device Record Key
- 35ccb251-2b03-48a4-a70d-1f52e24be806
Device Description
Umbilical Probe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63656 | Abdominal/ENT/orthopaedic surgical probe, single-use | A slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858778006850 | GS1 | ||||
| Package | 10858778006857 | GS1 | Box | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 2102262600
- [email protected]