FDA UDI
In Commercial Distribution
🇺🇸 United States
Labotek Spot Bandage
DI: 00850014448158
·
Model: RR-150
·
LABOTEK GROUP CORP
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- Labotek Spot Bandage
- Primary DI
- 00850014448158
- Version / Model
- RR-150
- Company Name
- LABOTEK GROUP CORP
- Labeler DUNS
- 117338398
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 1
- Public Version Date
- 2024-03-26
- Public Version Status
- New
- Public Device Record Key
- 0c65ed52-81b4-4eca-a2d1-7e196b6b342a
Device Description
Labotek Spot Bandage, 25 mm overall size, Ventilated, Individually wrapped
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34864 | Adhesive bandage | A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850014448165 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00850014448158 | GS1 | ||||
| Package | 10850014448162 | GS1 | Case | 192 | In Commercial Distribution | |
| Unit of Use | 10850014448155 | GS1 |
Customer Contacts
- Phone
- 7877851555
- [email protected]