FDA UDI
In Commercial Distribution
🇺🇸 United States
True5mm™ SUPERBAG
DI: 10850013527929
·
Model: PNI0120
·
Dannik LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- True5mm™ SUPERBAG
- Primary DI
- 10850013527929
- Version / Model
- PNI0120
- Catalog Number
- PNI0120
- Company Name
- Dannik LLC
- Labeler DUNS
- 117407001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2026-03-25
- Public Version
- 1
- Public Version Date
- 2026-04-02
- Public Version Status
- New
- Public Device Record Key
- 6267c4ac-ea13-4470-a3be-2c4f71518629
Device Description
PMI True5mm™ SUPERBAG Specimen Retrieval System, 120mL
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 Unsafe
- 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 |
|---|---|---|---|---|
| 48026 | Tissue extraction bag introducer | A sterile, hand-held, manual surgical instrument designed to introduce a folded tissue extraction bag into the patient's body through an appropriate access port during an endoscopic procedure. It is typically designed with a high-grade stainless steel stiff rod at the distal end around which the tissue extraction bag is folded and held in position with a gripping mechanism, e.g., prongs, and a handle at the proximal end. Once the bag is inside the body cavity, it is released and the introducer removed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850013527922 | GS1 | ||||
| Primary | 10850013527929 | GS1 |