FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Zutron Medical
DI: 00817658020003
·
Model: Endoscopy Procedure Kit
·
ZUTRON MEDICAL, L.L.C.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Zutron Medical
- Primary DI
- 00817658020003
- Version / Model
- Endoscopy Procedure Kit
- Catalog Number
- ZUTR40001
- Company Name
- ZUTRON MEDICAL, L.L.C.
- Labeler DUNS
- 962532441
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-01
- Public Version
- 7
- Public Version Date
- 2024-04-30
- Public Version Status
- Update
- Public Device Record Key
- dae1b554-1ee1-43d4-8223-2f3f8d443f4e
- Distribution End Date
- 2024-04-29
Device Description
Endoscopy Procedure Kit-Basin, Biopsy Valves, Gauze, Sponges, Lube, Vented Bag, Scope Tip Protector, Valve Bag, Transport Tote, Suction Tubing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817658020010 | GS1 | Box | 25 | Not in Commercial Distribution | 2024-04-29 |
| Primary | 00817658020003 | GS1 |