FDA UDI
In Commercial Distribution
🇺🇸 United States
Ahn Surgical Innovation, LLC
DI: 00860009955509
·
Model: TR231
·
AHN SURGICAL INNOVATION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ahn Surgical Innovation, LLC
- Primary DI
- 00860009955509
- Version / Model
- TR231
- Company Name
- AHN SURGICAL INNOVATION, LLC
- Labeler DUNS
- 114367387
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-02
- Public Version
- 1
- Public Version Date
- 2025-06-10
- Public Version Status
- New
- Public Device Record Key
- 9549e87b-5ba8-4b32-98ca-9fc74f1fff19
Device Description
Guide wire and surgical instrument organizational tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42891 | General-purpose bowl, single-use | A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009955509 | GS1 |
Customer Contacts
- Phone
- 2144491040
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 29 Degrees Celsius