FDA UDI
In Commercial Distribution
🇺🇸 United States
Cutimed® Siltec®
DI: 04042809557350
·
Model: 73287-00
·
BSN medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- Cutimed® Siltec®
- Primary DI
- 04042809557350
- Version / Model
- 73287-00
- Catalog Number
- 73287-00
- Company Name
- BSN medical GmbH
- Labeler DUNS
- 342651662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 2
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- a0dede45-625d-413f-a546-88c73b151833
Device Description
CUTIMED SILTEC SACRUM STERILE 17.5X17.5CM 5
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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAC | Dressing, wound, hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44970 | Exudate-absorbent dressing, non-gel, non-antimicrobial | A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04042809557367 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04042809557350 | GS1 | ||||
| Unit of Use | 04042809701227 | GS1 |
Customer Contacts
- Phone
- +1(800)537-1063
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17.5 | Centimeter | |
| Width | 17.5 | Centimeter |