FDA UDI
In Commercial Distribution
🇺🇸 United States
HolstOR Pro
DI: 09349967002919
·
Model: 410mm
·
THE O R COMPANY PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HolstOR Pro
- Primary DI
- 09349967002919
- Version / Model
- 410mm
- Catalog Number
- HPRO-410
- Company Name
- THE O R COMPANY PTY LTD
- Labeler DUNS
- 744346235
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-09
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- fce3ab62-e1e5-4519-bf5e-443b786f1a99
Device Description
Surgical Instrument Holder
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
- 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 |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35043 | Electrosurgical handpiece/electrode holder, reusable | A device used to house or fix an active electrosurgical conducting unit (handpiece/pen with its electrode) when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. This device will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09349967002926 | GS1 | Shipper Carton | 50 | In Commercial Distribution | |
| Primary | 09349967002919 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 410 | Millimeter |