FDA UDI
In Commercial Distribution
🇺🇸 United States
Microscope Slide Mailer
DI: 00810050854405
·
Model: SM0203
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Microscope Slide Mailer
- Primary DI
- 00810050854405
- Version / Model
- SM0203
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-17
- Public Version
- 1
- Public Version Date
- 2022-02-25
- Public Version Status
- New
- Public Device Record Key
- 639d4c61-b891-464c-b3b5-62a077163aa3
Device Description
CARDBOARD SLIDE MAILER W/ DIVIDERS & LID, FOR 1PC OF 25.0X75.0MM (1"X3") SLIDE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37537 | Microscope slide folder | A device designed to safely store stained microscope slides so that they are protected; particularly during transport/presentation of the slides. This device is available as flat folder in which the slides are placed flat into recesses and covered with a transparent or folding flap that will protect them. It may be colour-coded to help organize the slides and have a facility for labelling each slide (e.g., a bar-coded label). Some types are ready punched with holes suitable for storage in a ring binder. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810050854402 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00810050854405 | GS1 |