FDA UDI
In Commercial Distribution
🇺🇸 United States
Wallach EndoBlock Needle
DI: 20888937011207
·
Model: 920017
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wallach EndoBlock Needle
- Primary DI
- 20888937011207
- Version / Model
- 920017
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- a845a0cb-ae5a-4b4b-a870-6ff43369625f
Device Description
Endocervical Block Needle with Luer Lock Hub
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 |
|---|---|---|---|---|
| HEE | Set, Anesthesia, Paracervical | Obstetrics/Gynecology | 884.5100 | 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 |
|---|---|---|---|---|---|---|
| Primary | 20888937011207 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021224 | 000 |