FDA UDI
In Commercial Distribution
🇺🇸 United States
Raw Surgical Corporation
DI: G508RSC40906010
·
Model: HOOK
·
RAW SURGICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Raw Surgical Corporation
- Primary DI
- G508RSC40906010
- Version / Model
- HOOK
- Catalog Number
- RSC-4090601
- Company Name
- RAW SURGICAL CORPORATION
- Labeler DUNS
- 850405913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-01
- Public Version
- 1
- Public Version Date
- 2023-12-11
- Public Version Status
- New
- Public Device Record Key
- 1c0fc03e-94b8-429b-8294-7f4a97e0a72e
Device Description
KRAYENBUEHL HOOKS, Small, Probe pointed tip, with finger rest, Overall length 73/8" (18.7cm)
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61100 | Neurosurgical probe | A non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G508RSC40906010 | HIBCC |