FDA UDI
In Commercial Distribution
🇺🇸 United States
QKit Procedure Tray
DI: 00888937000047
·
Model: 909074
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- QKit Procedure Tray
- Primary DI
- 00888937000047
- Version / Model
- 909074
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-02
- Public Version
- 6
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 96863c5c-9c89-45eb-84f5-3d74ddcc2472
Device Description
For LOOP Electrosurgical Excision Procedure - contains Lidocaine with Epinephrine
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47061 | Cervical anaesthesia needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument used to administer an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gynaecological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically includes connectors for attachment to the piston of a syringe or intravascular administration set. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888937000041 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00888937000047 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935634 | 000 |