FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A.M.I.-dock Bluntdissect DLU 10mm
DI: EAMIA101310
·
Model: A10 131
·
AMI Agency for Medical Innovations GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- A.M.I.-dock Bluntdissect DLU 10mm
- Primary DI
- EAMIA101310
- Version / Model
- A10 131
- Catalog Number
- A10 131
- 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
- 2
- Public Version Date
- 2022-10-04
- Public Version Status
- Update
- Public Device Record Key
- e05a9fd9-9cd5-45e9-a16e-6a2c4a805b63
- Distribution End Date
- 2020-07-31
Device Description
Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
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
- 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
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 13698 | Dissection sponge | A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAMIA101310 | HIBCC | ||||
| Package | EAMIA101311 | HIBCC | 20 | Not in Commercial Distribution | 2020-07-31 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 28 | Millimeter | |
| Outer Diameter | 8 | Millimeter |