FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Surgical Direct
DI: B382SD166100
·
Model: SD 16610
·
Surgical Direct, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgical Direct
- Primary DI
- B382SD166100
- Version / Model
- SD 16610
- Catalog Number
- SD 16610
- Company Name
- Surgical Direct, Inc.
- Labeler DUNS
- 124367223
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-06
- Public Version
- 2
- Public Version Date
- 2024-04-17
- Public Version Status
- Update
- Public Device Record Key
- 53abb399-ac42-47b2-9ba3-afe628be61ef
- Distribution End Date
- 2023-04-12
Device Description
5mm Oviduct Atraumatic Grasper, Standard Length
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
- No
- 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 |
|---|---|---|---|---|
| 33199 | Flexible endoscopic tissue manipulation forceps, single-use | A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B382SD166100 | HIBCC |
Customer Contacts
- Phone
- +1 (800) 519-3293
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974382 | 000 |