FDA UDI
In Commercial Distribution
🇺🇸 United States
GEM 21S®
DI: 00850001118002
·
Model: LBGEM05
·
LYNCH BIOLOGICS, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GEM 21S®
- Primary DI
- 00850001118002
- Version / Model
- LBGEM05
- Company Name
- LYNCH BIOLOGICS, LLC
- Labeler DUNS
- 079604282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-18
- Public Version
- 1
- Public Version Date
- 2018-11-19
- Public Version Status
- New
- Public Device Record Key
- 457b7521-fbca-448d-b068-74c0a7031f94
Device Description
Growth-Factor Enhanced Matrix for Periodontal Regeneration
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
- 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 |
|---|---|---|---|---|
| NPZ | Bone Grafting Material, Dental, With Biologic Component | Dental | 872.3930 | 3 |
| NQA | Biologic Material, Dental | Dental | 872.3930 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45481 | Periodontal root surface regeneration material | A bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. It is typically presented in the form of a gel, or as a solution and enamel matrix material that is mixed into a gel prior to application. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850001118002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040013 | 000 |
| P040013 | 014 |
| P040013 | 015 |
| P040013 | 016 |
| P040013 | 018 |
| P040013 | 020 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.5 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius