FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Direct
DI: B382SD3969890
·
Model: SD396989
·
Surgical Direct, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Surgical Direct
- Primary DI
- B382SD3969890
- Version / Model
- SD396989
- Catalog Number
- SD396989
- Company Name
- Surgical Direct, Inc.
- Labeler DUNS
- 124367223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-03
- Public Version
- 1
- Public Version Date
- 2024-12-11
- Public Version Status
- New
- Public Device Record Key
- a93eea80-655f-417e-be59-fb52a4dc65a0
Device Description
5mm 33cm Disposable Metzenbaum Scissors, Blue Rotator Knob, Curved with Monopolar Non-Locking – Single Use
Device Characteristics
- Single Use
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63163 | Rigid endoscopic scissors, single-use | A sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B382SD3969890 | HIBCC |
Customer Contacts
- Phone
- +1 (800) 519-3293
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142208 | 000 |