FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00812277031003
·
Model: 1841-14005
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00812277031003
- Version / Model
- 1841-14005
- Catalog Number
- 1841-14005
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-15
- Public Version
- 2
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- d0035eb4-d9e0-4390-bb9e-6ad8037824cc
Device Description
Curaplex Transparent Surgical Tape, 10 yds, 3"
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
- 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
- Yes
- 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 side 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 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 |
|---|---|---|---|---|---|---|
| Package | 00812277031126 | GS1 | BOX | 4 | In Commercial Distribution | |
| Primary | 00812277031003 | GS1 | ||||
| Package | 00812277031249 | GS1 | CASE | 12 | In Commercial Distribution |