FDA UDI
In Commercial Distribution
🇺🇸 United States
Symmetry Erich
DI: 00887482156742
·
Model: 68-1510
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Symmetry Erich
- Primary DI
- 00887482156742
- Version / Model
- 68-1510
- Catalog Number
- 68-1510
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-20
- Public Version
- 5
- Public Version Date
- 2025-10-29
- Public Version Status
- Update
- Public Device Record Key
- 77860f25-96f6-437c-a56e-70f446739a32
Device Description
Symmetry® Bars, Erich Arch, 5 1/2 in, 139 mm, (12/pk)
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44808 | Maxillofacial bone wire/bar | A length of metal (e.g., stainless steel) intended to stabilize bony fragments (fractured bone) in the oral cavity and/or stabilize injured teeth. Stabilization occurs by direct application of the device to the bone/teeth (e.g., by wrapping the ligature around fractured bone segments and locking the ends together). The device may be used for intermaxillary fixation, maxillomandibular fixation, or other forms of jaw immobilization. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887482156742 | GS1 |
Customer Contacts
- Phone
- +1 888-364-7004
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.5 | Inch |