FDA UDI
In Commercial Distribution
🇺🇸 United States
SUREPRESS
DI: 00768455108961
·
Model: 650948
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- SUREPRESS
- Primary DI
- 00768455108961
- Version / Model
- 650948
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-09-05
- Public Version
- 4
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 75d95aa7-6947-48d6-9075-e4f717d5d1c0
Device Description
SUREPRESS ABSORB PAD (1X6PK) INT
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
- 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 |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48131 | Non-woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455108968 | GS1 | Shipper | 24 | In Commercial Distribution | |
| Primary | 00768455108961 | GS1 | ||||
| Unit of Use | 80768455108967 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10 | Centimeter | |
| Length | 3 | Meter |