FDA UDI
In Commercial Distribution
🇺🇸 United States
Endo Carry-on Procedure Kit
DI: 00677964153365
·
Model: 4011161
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Endo Carry-on Procedure Kit
- Primary DI
- 00677964153365
- Version / Model
- 4011161
- Catalog Number
- 4011161
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- adce3742-bbc9-4742-bde3-7e117f747cd4
Device Description
Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Pentax 4-piece Kit Radial, Transport Pad, Lubricant, Gauze, Verify Resi-Test Slide-Thru Brush, and Biohazard Sticker.
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 | 50677964153360 | GS1 | Box | 28 | In Commercial Distribution | |
| Primary | 00677964153365 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]