FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydro-Surg
DI: 00801741000362
·
Model: 0026870
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Hydro-Surg
- Primary DI
- 00801741000362
- Version / Model
- 0026870
- Catalog Number
- 0026870
- 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
- bb93cb9f-cf06-4bc0-be89-291b65617c91
Device Description
Hydro-Surg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33 cm Tip and Cojoined Suction and Irrigation Tubing
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 |
|---|---|---|---|---|
| 65140 | Surgical irrigation/aspiration pump, single-use | An electrically-powered device intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, in conjunction with a patient contact device (not included), usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include noninvasive accessories (e.g., collection container, tubing); it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801741000366 | GS1 | CA | 2 | In Commercial Distribution | |
| Package | 10801741000369 | GS1 | BX | 5 | In Commercial Distribution | |
| Primary | 00801741000362 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 33 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius