FDA UDI
In Commercial Distribution
🇺🇸 United States
Symmetry Rumel
DI: 00887482043622
·
Model: 55-5498
·
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 Rumel
- Primary DI
- 00887482043622
- Version / Model
- 55-5498
- Catalog Number
- 55-5498
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-12
- Public Version
- 4
- Public Version Date
- 2025-10-29
- Public Version Status
- Update
- Public Device Record Key
- 56ab582c-9cfa-4fa7-bead-53030fa04793
Device Description
Symmetry® Obturator, Rumel, Adult
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 |
|---|---|---|---|---|
| EYR | Tourniquet, Gastro-Urology | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45921 | Tracheostomy tube obturator | A device designed to fill the lumen of a tracheostomy tube during its insertion into the stoma created in the larynx (windpipe) to assist in this process, reduce patient trauma, and prevent any tissue damage. When the tracheostomy tube is correctly positioned the obturator is removed. It is typically a thin rod with a bulbous rounded distal end that protrudes out of the tracheostomy tube, and a knob-like handle used to remove it. It is typically made of a high-grade stainless steel and/or silver (Ag) or silver plated brass. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887482043622 | GS1 |
Customer Contacts
- Phone
- +1 888-364-7004
- [email protected]