FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Padlock Clip-12
DI: 00864345000008
·
Model: C910001
·
APONOS MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Padlock Clip-12
- Primary DI
- 00864345000008
- Version / Model
- C910001
- Catalog Number
- C910001
- Company Name
- APONOS MEDICAL CORPORATION
- Labeler DUNS
- 829951404
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d0742cf7-7bbc-47af-be51-b3da2b242564
- Distribution End Date
- 2017-12-14
Device Description
Endoscopic Ligation Clip
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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38144 | Wound clip, non-biodegradable | A device designed for the temporary, atraumatic approximation of the edges of a wound during a surgical procedure. It is typically a small, usually metallic, instrument with two blades joined at the mid-portion, or made of a single alpha-shaped part. It is typically applied manually. The device is mainly used to arrest bleeding (i.e., haemostasis); it may be used to facilitate the placing of sutures to close wounds. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864345000008 | GS1 |
Customer Contacts
- Phone
- 603-347-8229
- [email protected]