FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgilube
DI: 00851809002425
·
Model: 281020502
·
HR PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
2
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgilube
- Primary DI
- 00851809002425
- Version / Model
- 281020502
- Catalog Number
- 281020502
- Company Name
- HR PHARMACEUTICALS INC.
- Labeler DUNS
- 828918164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-27
- Public Version
- 3
- Public Version Date
- 2024-06-17
- Public Version Status
- Update
- Public Device Record Key
- 0189314a-cb4c-4e3c-8cdd-7df9b2222760
Device Description
Sterile Surgical Lubricant, Metal Tube
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMJ | Lubricant, patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60795 | Multi-purpose surgical instrument lubricant | A sterile substance intended to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient); it is not dedicated to a specific type of surgical instrument. It includes plant-derived materials (e.g., glycerin) and may also be intended for non-surgical applications (e.g., entry of a device into a body orifice). After application, this device cannot be reused. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Package | 20851809002429 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 10851809002422 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00851809002425 | GS1 | ||||
| Secondary | 00281020502 | NDC/NHRIC |
Customer Contacts
- Phone
- +1(717)252-1110 ext. 109
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 56.7 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius