FDA UDI
In Commercial Distribution
🇺🇸 United States
Symmetry Jannetta
DI: 00887482103784
·
Model: 58-6201
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Symmetry Jannetta
- Primary DI
- 00887482103784
- Version / Model
- 58-6201
- Catalog Number
- 58-6201
- 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
- 5
- Public Version Date
- 2025-10-29
- Public Version Status
- Update
- Public Device Record Key
- 61753d94-d787-4209-ac02-d96427172afc
Device Description
Symmetry® Knife, Jannetta, Angled, Small, 7 1/2 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
- 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 |
|---|---|---|---|---|
| GZX | Instrument, Microsurgical | Neurology | 882.4525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35143 | Sternum knife | A heavy-duty, hand-held manual surgical instrument designed for cutting into the sternum (the breastbone). It typically has a T-shaped handle to allow the application of pressure to the blade which descends from the handle in a thick shaft terminating in various contours. It is typically made of high-grade stainless steel; its handle may be made of a synthetic polymer (e.g., Tufnol). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887482103784 | GS1 |
Customer Contacts
- Phone
- +1 888-364-7004
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.25 | Inch |