FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Richard-Allan® Tonsil Snare
DI: 00887761005587
·
Model: 2408
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Richard-Allan® Tonsil Snare
- Primary DI
- 00887761005587
- Version / Model
- 2408
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-12-06
- Public Version
- 4
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- 029d6c0e-2a09-485d-86ea-94184e09f3ab
- Distribution End Date
- 2023-06-16
Device Description
Snares are intended to be used with snare gun for removal of tonsil and nasal polyps.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KBZ | SNARE, TONSIL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13632 | Tonsil snare | A manual surgical instrument inserted into the oral cavity to remove the tonsils during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the root of the tonsil to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10887761005584 | GS1 | 50 | Not in Commercial Distribution | 2023-06-16 | |
| Primary | 00887761005587 | GS1 | ||||
| Unit of Use | 80887761005583 | GS1 |
Customer Contacts
- Phone
- +1(616)698-7100
- [email protected]