FDA UDI
In Commercial Distribution
🇺🇸 United States
Bluemed Surgical
DI: G0332602350
·
Model: Kern Bone Holding Forcep
·
BLUEMED SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bluemed Surgical
- Primary DI
- G0332602350
- Version / Model
- Kern Bone Holding Forcep
- Catalog Number
- 26-0235
- Company Name
- BLUEMED SURGICAL
- Labeler DUNS
- 645829172
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-25
- Public Version
- 1
- Public Version Date
- 2022-08-02
- Public Version Status
- New
- Public Device Record Key
- cf47026b-36ac-4b25-aeeb-149c4460068b
Device Description
15.5 cm Jaw 7.5 mm
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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46751 | Bone holding forceps | A manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G0332602351 | HIBCC | Poly Bag | 20 | In Commercial Distribution | |
| Primary | G0332602350 | HIBCC |