FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort Drain Grasper
DI: EAMICDS20100
·
Model: CDS2010
·
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
- Comfort Drain Grasper
- Primary DI
- EAMICDS20100
- Version / Model
- CDS2010
- Catalog Number
- CDS2010
- Company Name
- AMI Agency for Medical Innovations GmbH
- Labeler DUNS
- 303655286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-29
- Public Version
- 1
- Public Version Date
- 2018-12-31
- Public Version Status
- New
- Public Device Record Key
- 12d89bf9-e535-422c-8f4a-f967e475da20
Device Description
For easy closure the Comfort Drain Grasper can be used as a helpful instrument to connect the coupling piece with the cut / trimmed drain during the implantation of a Comfort Drain.
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
- 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 |
|---|---|---|---|---|
| GBN | Catheter, Pediatric, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62996 | Implant handling forceps, tweezers-like | A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on tissues and is not a dedicated tissue clip applier. It has a tweezers-like design (may be a micro/fine instrument) whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of metal, available in various sizes/designs, and is commonly dedicated to a proprietary implant. This is a reusable device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAMICDS20100 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 21 | Gram | |
| Width | 17 | Micrometer | |
| Length | 130.5 | Millimeter |