FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydro-Surg
DI: 00801741010200
·
Model: 0026110
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hydro-Surg
- Primary DI
- 00801741010200
- Version / Model
- 0026110
- Catalog Number
- 0026110
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-03
- Public Version
- 4
- Public Version Date
- 2024-10-22
- Public Version Status
- Update
- Public Device Record Key
- 697de85c-38b4-424e-9c8d-4c2d5bebdac1
- Distribution End Date
- 2029-01-16
Device Description
Dual Spike Adapter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66959 | Surgical irrigation/aspiration Y-piece connector | A tubular device designed with two inlets and one outlet openings intended to enable appropriate connection between a surgical/aspiration system/pump (e.g., connects to the pump spike) and the tubing lines that connect to a dual irrigation bag configuration. It may also be referred to as a dual spike adaptor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741010207 | GS1 | CA | 20 | In Commercial Distribution | 2029-01-16 |
| Primary | 00801741010200 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch |