FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00810094575656
·
Model: 1212-12112
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00810094575656
- Version / Model
- 1212-12112
- Catalog Number
- 1212-12112
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-04-30
- Public Version
- 1
- Public Version Date
- 2023-05-08
- Public Version Status
- New
- Public Device Record Key
- 348c69f6-2ac1-42f6-873b-67343d8dcdec
Device Description
CURAPLEX STERILE, GAUZE SPONGE, WOVEN, 2IN X 2IN, 8-PLY, 2EA/PK, 50PK/BX, 30BX/CS
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48134 | Woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810094575694 | GS1 | Inner Box | 50 | In Commercial Distribution | |
| Primary | 00810094575656 | GS1 | ||||
| Package | 00810094575731 | GS1 | Master Case | 30 | In Commercial Distribution | |
| Unit of Use | 00810094575618 | GS1 |