FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Custom Procedure Kit
DI: 40677964023482
·
Model: 4003535
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Custom Procedure Kit
- Primary DI
- 40677964023482
- Version / Model
- 4003535
- Catalog Number
- 4003535
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 7
- Public Version Date
- 2025-11-14
- Public Version Status
- Update
- Public Device Record Key
- 62ac25c2-6532-47bc-b647-ca511d562130
- Distribution End Date
- 2025-11-13
Device Description
Endo Carry-on Procedure Kit includes Suction Tubing, Olyumpus 5-piece DCA Kit, Enzymatic Sponge, Tray, Gauze, Drawstring Pad, and Lubricant,
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NWU | Endoscope introducer kit | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61950 | Endoscopy preparation kit | A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40677964023499 | GS1 | Case | 18 | Not in Commercial Distribution | 2025-11-13 |
| Primary | 40677964023482 | GS1 |
Customer Contacts
- Phone
- +1(800)444-4729
- [email protected]