FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoGlide+™
DI: 06921865500105
·
Model: M00501903
·
Jianerkang Medical Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- EndoGlide+™
- Primary DI
- 06921865500105
- Version / Model
- M00501903
- Catalog Number
- M00501903
- Company Name
- Jianerkang Medical Co., Ltd
- Labeler DUNS
- 530968767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-15
- Public Version
- 5
- Public Version Date
- 2024-06-24
- Public Version Status
- Update
- Public Device Record Key
- 78f85fd0-da70-46de-9df2-7b8bb251426d
Device Description
1.1oz Lubricant Gel
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KMJ | Lubricant, Patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60796 | General-body orifice lubricant | A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06921865500105 | GS1 | ||||
| Package | 16921865500027 | GS1 | 20 | In Commercial Distribution | ||
| Package | 26921865500048 | GS1 | 5 | In Commercial Distribution |