FDA UDI
In Commercial Distribution
🇺🇸 United States
Apple-Hunt Laparoscopic Instrument Organizer
DI: 00888937014754
·
Model: 900-305
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Apple-Hunt Laparoscopic Instrument Organizer
- Primary DI
- 00888937014754
- Version / Model
- 900-305
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- db1d68cd-4d45-44b9-a9e0-53cfaa37caed
Device Description
Hunt Instrument Organizer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58968 | Instrument management bag | A flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888937014758 | GS1 | 2 | 50 | In Commercial Distribution | |
| Primary | 00888937014754 | GS1 |