FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A.M.I.-dock Applicator Short 10mm
DI: EAMIA101120
·
Model: A10 112
·
AMI Agency for Medical Innovations GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- A.M.I.-dock Applicator Short 10mm
- Primary DI
- EAMIA101120
- Version / Model
- A10 112
- Catalog Number
- A10 112
- Company Name
- AMI Agency for Medical Innovations GmbH
- Labeler DUNS
- 303655286
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-28
- Public Version
- 3
- Public Version Date
- 2022-10-04
- Public Version Status
- Update
- Public Device Record Key
- 4d27ec75-4f04-4a33-95a3-a1251ba4389b
- Distribution End Date
- 2022-09-30
Device Description
Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic multiple use carrier to operate the A.M.I.-dock Disposable Loading Units (DLU).
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63868 | Laparoscopic surgery handle | A hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAMIA101120 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 392 | Millimeter | |
| Outer Diameter | 10 | Millimeter |