FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile Labels
DI: B050SL1000020
·
Model: SL-100002
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Sterile Labels
- Primary DI
- B050SL1000020
- Version / Model
- SL-100002
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-17
- Public Version
- 1
- Public Version Date
- 2026-03-25
- Public Version Status
- New
- Public Device Record Key
- 180a264e-a90f-40b9-b6ff-3c138db88f20
Device Description
Sterile Label Kit: 1 - 10 UP Custom Printed Label Sheet 1 - Utility Marker
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYV | Label Or Tag, Sterile | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47731 | Procedural medication labelling set | A collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B050SL1000021 | HIBCC | Case | 25 | In Commercial Distribution | |
| Primary | B050SL1000020 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 75 Degrees Fahrenheit