FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Salvin OraMEM™ Absorbable Collagen Membrane
DI: 10381780072591
·
Model: #ORAMEM30X40
·
Integra Lifesciences Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Salvin OraMEM™ Absorbable Collagen Membrane
- Primary DI
- 10381780072591
- Version / Model
- #ORAMEM30X40
- Catalog Number
- #ORAMEM30X40
- 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
- 9
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 3ad91f78-b205-43ea-98d8-83f48a02f4ed
- Distribution End Date
- 2020-03-31
Device Description
ORAMEM 30x40 OraMem absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. The OraMem membrane is completely absorbable, eliminating the need for the second surgical procedure often required to remove a non-resorbabble membrane. The collage 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 | 30381780072595 | GS1 | CAS | 12 | Not in Commercial Distribution | 2020-03-31 |
| Primary | 10381780072591 | GS1 | ||||
| Secondary | M269ORAMEM30X401 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 30mmx40mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The product should be stored at room temperature. Avoid excessive heat and humidity.