FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Direct
DI: B382SD982430
·
Model: SD98243
·
Surgical Direct, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surgical Direct
- Primary DI
- B382SD982430
- Version / Model
- SD98243
- Catalog Number
- SD98243
- Company Name
- Surgical Direct, Inc.
- Labeler DUNS
- 124367223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-26
- Public Version
- 1
- Public Version Date
- 2020-05-04
- Public Version Status
- New
- Public Device Record Key
- a60caf93-ffd3-42ad-a9f3-54506ab99b33
Device Description
5mm 33cm Biopsy Punch Forcep, with Teeth, Stainless Steel Handle, with On/Off Ratchet
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62667 | Laparoscopic tissue manipulation forceps/working-channel | A rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B382SD982430 | HIBCC |
Customer Contacts
- Phone
- +1 (800) 519-3293
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914910 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 33 | Centimeter | |
| Outer Diameter | 5 | Millimeter |