FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pilling
DI: 00190776026707
·
Model: P44880
·
Avalign Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pilling
- Primary DI
- 00190776026707
- Version / Model
- P44880
- Company Name
- Avalign Technologies, Inc.
- Labeler DUNS
- 792528510
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-23
- Public Version
- 4
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- 8e9372f0-187d-428f-b17d-57aaa7073677
- Distribution End Date
- 2023-11-21
Device Description
McGivney hemorrhoidal Ligator, Includes Cone and O-Rings, Latex O-Rings, Cone Material is Polyoxymethylene Nature
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FHN | Ligator, hemorrhoidal | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35157 | Haemorrhoid ligator | A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190776026707 | GS1 |
Customer Contacts
- Phone
- +1(877)289-1096
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Inch |