FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A.M.I. TissueBag Premium 5 mm
DI: EAMITBI10310
·
Model: TBI1031
·
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. TissueBag Premium 5 mm
- Primary DI
- EAMITBI10310
- Version / Model
- TBI1031
- Catalog Number
- TBI1031
- 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
- 2023-11-28
- Public Version Status
- Update
- Public Device Record Key
- 2e422954-ddb0-484f-b640-b7e58f3ae68a
- Distribution End Date
- 2023-11-21
Device Description
Bag for retrieving specimen for 5 mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
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
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45130 | Tissue extraction bag | An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAMITBI10310 | HIBCC | ||||
| Package | EAMITBI10311 | HIBCC | 10 | Not in Commercial Distribution | 2023-11-21 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 515 | Millimeter |