FDA UDI
In Commercial Distribution
🇺🇸 United States
Microscope Slide Mailer
DI: 00810050854375
·
Model: SM0102
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Microscope Slide Mailer
- Primary DI
- 00810050854375
- Version / Model
- SM0102
- 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
- f804580a-286f-47f4-b657-f02f1a18fbda
Device Description
SLIDES MAILER FOR 2 PCS OF 25.0X75.0MM (1"X3") SLIDES, HORIZONTAL TYPE, PP MATERIAL. NEUTRAL COLOR
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 |
|---|---|---|---|---|
| 37975 | Microscope slide box | A small, portable box intended to be used to safely store a number of stained microscope slides for their organization and protection during storage and transportation. It will typically have the capacity to store, e.g., 12 to 100 slides, and is available in a variety of box designs, e.g., it may have a hinged or a loose lid which may be transparent. The slides are stored upright lying on one side. Some types may facilitate stacking, one upon another, with interlocking recesses to keep them together. This device can be made of plastic, wood, and metal materials and will typically include labels to show content. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810050854372 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00810050854375 | GS1 |