Salvin OraMem®
Basic Information
- Brand Name
- Salvin OraMem®
- Primary DI
- 10381780072614
- Version / Model
- #ORAMEMSUS20X30
- Catalog Number
- #ORAMEMSUS20X30
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-22
- Public Version
- 8
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- d40c1d35-bb8d-4139-ae9a-5ce7266e5075
- Distribution End Date
- 2020-03-31
Device Description
#ORAMEM SUS 20x30 OraMem Sustained absorbable collagen membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. OraMem Sustained absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achillies) tendon. Bovine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial amounts. The OraMem Sustained membrane is completely absorbable, eliminating the need for the second surgical procedure required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.
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 |
|---|---|---|---|---|
| LYC | Bone grafting material, synthetic | 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 |
|---|---|---|---|---|---|---|
| Package | 30381780072618 | GS1 | CAS | 12 | Not in Commercial Distribution | 2020-03-31 |
| Primary | 10381780072614 | GS1 | ||||
| Secondary | M269ORAMEMSUS20X301 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992216 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20mmx30mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The product should be stored at room temperature. Avoid excessive heat and humidity.