FDA UDI
In Commercial Distribution
🇺🇸 United States
Geistlich Mucograft® Seal
DI: 07610221014545
·
Model: 500726
·
Geistlich Pharma AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Geistlich Mucograft® Seal
- Primary DI
- 07610221014545
- Version / Model
- 500726
- Company Name
- Geistlich Pharma AG
- Labeler DUNS
- 480781728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-01
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- ec3a3c3a-26f6-4ae1-a1bf-b1cc6d82b369
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58740 | Dental/maxillofacial soft-tissue biomatrix implant, animal-derived | A bioabsorbable animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07610221014545 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter |