FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSI
DI: 00841645101413
·
Model: ASSI.00608
·
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASSI
- Primary DI
- 00841645101413
- Version / Model
- ASSI.00608
- 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
- 2023-08-10
- Public Version
- 1
- Public Version Date
- 2023-08-18
- Public Version Status
- New
- Public Device Record Key
- 44619a30-eb5d-434f-bdb1-00699619e36b
Device Description
Micro Tubing Introducer Fcps, 11cm For Microcatheter 0.35mm Dia.
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 |
|---|---|---|---|---|
| HNR | Forceps, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31264 | Airway tube forceps, reusable | A hand-held instrument used for grasping a tube [e.g., a catheter or an endotracheal (ET) tube] for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. Commonly known as a Magill's forceps, it typically has a scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have grasping blades that have small ringed loops or S-shaped distal working ends. The blades are serrated to provide extra grip. It is typically used by emergency medical services (EMS). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841645101413 | GS1 |