FDA UDI
In Commercial Distribution
🇺🇸 United States
Solventum™ Promogran Prisma™
DI: 00197998118654
·
Model: MA032
·
Solventum US LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Solventum™ Promogran Prisma™
- Primary DI
- 00197998118654
- Version / Model
- MA032
- Catalog Number
- MA032
- Company Name
- Solventum US LLC
- Labeler DUNS
- 119004140
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-10
- Public Version
- 1
- Public Version Date
- 2026-04-20
- Public Version Status
- New
- Public Device Record Key
- 17edb58d-64ff-4719-a2b3-31e2423a3057
Device Description
Solventum™ Promogran Prisma™ Collagen Matrix with ORC and Silver, MA032, 3/8 in x 3/8 in x 12 5/8 in, 6/CAR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Animal-derived wound matrix dressing | A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00197998118678 | GS1 | CASE | 24 | In Commercial Distribution | |
| Primary | 00197998118654 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]