FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693228831
·
Model: Tissue Specimen Bags Small, Qty. 200 Blue Nylon
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RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693228831
- Version / Model
- Tissue Specimen Bags Small, Qty. 200 Blue Nylon
- Catalog Number
- 6774014
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-10
- Public Version
- 1
- Public Version Date
- 2024-09-18
- Public Version Status
- New
- Public Device Record Key
- 5320d219-d38a-4d6e-bb8a-f4cf5c8e4597
Device Description
Tissue Specimen Bags are designed to contain small tissue fragments and biopsies during tissue processing. Acid-resistant bags feature all of the benefits of nylon specimen bags, plus offer acid resistance for decalcification. Tissue Specimen bags are used in addition to tissue cassettes during processing. They are available in blue nylon (mono-filament, hydrophilic coated); white nylon (mono-filament, mono-filament - hydrophilic coated and polyester acid-resistant, woven).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IDZ | Cassettes, Tissue | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63838 | General tissue specimen container IVD, no additive | A covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693228831 | GS1 |