FDA UDI
In Commercial Distribution
🇺🇸 United States
Avaline Medical NJ LLC
DI: 00810124533335
·
Model: ST 3IN X24
·
Avaline Medical NJ Limited Liability Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
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Basic Information
- Brand Name
- Avaline Medical NJ LLC
- Primary DI
- 00810124533335
- Version / Model
- ST 3IN X24
- Company Name
- Avaline Medical NJ Limited Liability Company
- Labeler DUNS
- 079767953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2025-06-27
- Public Version
- 2
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 0e0e78f4-16ca-496e-8fee-4196c21ee282
Device Description
Paper Surgical Tape 3 inch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KGX | Tape and bandage, adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58986 | Multi-purpose surgical skin adhesive tape | A long thin band of synthetic material coated on one or both sides with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or a combination of materials. 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 | 00810124533250 | GS1 | ||||
| Primary | 00810124533335 | GS1 |
Customer Contacts
- Phone
- +1(732)813-7799 ext. 204
- [email protected]