FDA UDI
In Commercial Distribution
🇺🇸 United States
BR Surgical, LLC
DI: 00840183515591
·
Model: BR966-8019-700
·
BR Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BR Surgical, LLC
- Primary DI
- 00840183515591
- Version / Model
- BR966-8019-700
- Catalog Number
- BR966-8019-700
- Company Name
- BR Surgical, LLC
- Labeler DUNS
- 134781207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-25
- Public Version
- 1
- Public Version Date
- 2023-11-02
- Public Version Status
- New
- Public Device Record Key
- 8067ea30-dde4-4731-9414-bdb45cf32b43
Device Description
Flexible Rat Tooth Grasping Forceps, with single thumb ring handle, 1x2 tooth(shark tooth), 8mm opening, 1.8mm x 700mm
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
- Yes
- 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
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
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 |
|---|---|---|---|---|
| 35524 | Flexible endoscopic tissue manipulation forceps, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840183515591 | GS1 |
Customer Contacts
- Phone
- 1-904-642-1366
- [email protected]