FDA UDI
In Commercial Distribution
🇺🇸 United States
LabChoice Embedding Rings, White
DI: 00840117337305
·
Model: 42500
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- LabChoice Embedding Rings, White
- Primary DI
- 00840117337305
- Version / Model
- 42500
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2025-03-05
- Public Version
- 1
- Public Version Date
- 2025-03-13
- Public Version Status
- New
- Public Device Record Key
- 8b5835f2-b2e0-4980-9dc4-cd597b93b776
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IDZ | Cassettes, Tissue | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63813 | Tissue embedding mould holder IVD | A preformed plastic device intended to contain and hold a tissue embedding mould during an embedding procedure (e.g., in paraffin wax) to form a tissue solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It may also be referred to as an embedding ring and typically has a writing surface to facilitate specimen identification. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810180841283 | GS1 | ||||
| Primary | 00840117337305 | GS1 | ||||
| Package | 00840117335165 | GS1 | Case | 4 | In Commercial Distribution |