FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Handle for 10mm
DI: B3544449
·
Model: 444
·
ORANGE SURGICAL INSTRUMENTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
99999
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Basic Information
- Brand Name
- Handle for 10mm
- Primary DI
- B3544449
- Version / Model
- 444
- Company Name
- ORANGE SURGICAL INSTRUMENTS, LLC
- Labeler DUNS
- 047063695
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 99999
- Record Status
- Published
- Publish Date
- 2023-08-07
- Public Version
- 2
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- 21b05e6c-8f24-44ab-9a34-00896380112f
- Distribution End Date
- 2023-08-07
Device Description
Handle for 10mm
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
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61875 | Endoscopic electrosurgical electrode, monopolar, single-use | A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B35400 | HIBCC | ||||
| Primary | B3544449 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101733 | 000 |