FDA UDI
In Commercial Distribution
🇺🇸 United States
Telfa
DI: 30884521154081
·
Model: 12388AMD
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Telfa
- Primary DI
- 30884521154081
- Version / Model
- 12388AMD
- Catalog Number
- 12388AMD
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 4
- Public Version Date
- 2022-11-30
- Public Version Status
- Update
- Public Device Record Key
- 49c61c2a-c0d8-4152-8042-244a7f06a023
Device Description
AMD Antimicrobial Non-adherent Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
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
- No
- 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 |
|---|---|---|---|---|
| EFQ | GAUZE/SPONGE, INTERNAL | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46854 | Wound-nonadherent dressing, absorbent, non-antimicrobial | A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521154084 | GS1 | CASE | 4000 | In Commercial Distribution | |
| Primary | 30884521154081 | GS1 | ||||
| Unit of Use | 40884521154088 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Width | 3 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side up;