FDA UDI
In Commercial Distribution
🇺🇸 United States
RCM6 Resorbable Collagen Membrane, RCP, NuOss, Conform
DI: 00614950007837
·
Model: 5099000
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RCM6 Resorbable Collagen Membrane, RCP, NuOss, Conform
- Primary DI
- 00614950007837
- Version / Model
- 5099000
- Catalog Number
- 5099000
- Company Name
- ACE SURGICAL SUPPLY CO., INC.
- Labeler DUNS
- 042763706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2019-05-07
- Public Version Status
- Update
- Public Device Record Key
- c20c5a39-4d66-4a1f-b8f7-8b6c303bb01c
Device Description
Introductory Grafting Kit
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
- 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 |
|---|---|---|---|---|
| NPM | BONE GRAFTING MATERIAL, ANIMAL SOURCE | Dental | 872.3930 | 2 |
| NPL | Barrier, animal source, intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45147 | Dental/maxillofacial surgical procedure kit, non-medicated, reusable | A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614950007837 | GS1 |
Customer Contacts
- Phone
- +1(508)588-3100 ext. 214
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 15 | Millimeter | |
| Width | 1 | Centimeter | |
| Width | 20 | Millimeter | |
| Device Size Text, specify | 8mm x 9mm x 9mm | ||
| Device Size Text, specify | 6mm x 7mm x 8mm | ||
| Weight | 0.25 | Gram | |
| Weight | 0.5 | Gram |