FDA UDI
In Commercial Distribution
🇺🇸 United States
Symmetry Doyen
DI: 00887482049402
·
Model: 52-5001
·
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 Doyen
- Primary DI
- 00887482049402
- Version / Model
- 52-5001
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 3
- Public Version Date
- 2025-10-29
- Public Version Status
- Update
- Public Device Record Key
- 75214853-cd04-4ac5-8b1f-ad4dc2afa8fb
Device Description
Symmetry® Screw; Doyen Tumor; 6 3/4 in
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
- Yes
- 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 |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35874 | Myoma screw, reusable | A hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887482049402 | GS1 |
Customer Contacts
- Phone
- +1 888-364-7004
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.75 | Inch |