FDA UDI
In Commercial Distribution
🇺🇸 United States
Pilling
DI: 00190776078010
·
Model: P19095
·
Avalign Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pilling
- Primary DI
- 00190776078010
- Version / Model
- P19095
- Company Name
- Avalign Technologies, Inc.
- Labeler DUNS
- 792528510
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-03
- Public Version
- 3
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- b0c3c112-490f-44f9-8cb5-336a34be596f
Device Description
PUNCH KERR MICRO 9MM OPENING
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| HAE | RONGEUR, MANUAL | Neurology | 882.4840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13418 | Neurosurgical rongeur | A hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190776078010 | GS1 |
Customer Contacts
- Phone
- +1(877)289-1096
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch |