FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSI
DI: 00841645125624
·
Model: ASSI.AEP724236
·
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASSI
- Primary DI
- 00841645125624
- Version / Model
- ASSI.AEP724236
- Company Name
- ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
- Labeler DUNS
- 055870299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-08
- Public Version
- 1
- Public Version Date
- 2020-07-16
- Public Version Status
- New
- Public Device Record Key
- a35bc5d2-1102-4f41-8eb6-f2e3bde8d257
Device Description
Nerve Hook, 24cm, Half Cvd., Finely Tapered, Right Angle Hook
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 |
|---|---|---|---|---|
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46768 | Nerve/vessel retractor | A hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841645125624 | GS1 |