FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambler Surgical
DI: 10190660197947
·
Model: Tympanoplasty blade
·
AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ambler Surgical
- Primary DI
- 10190660197947
- Version / Model
- Tympanoplasty blade
- Catalog Number
- 7200
- Company Name
- AMBLER SURGICAL CORP.
- Labeler DUNS
- 015272206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-07
- Public Version
- 2
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 8781f6ac-1118-41e1-ac66-7507ce2214bc
Device Description
Tympanoplasty blade, angled 60 degrees, 2.5mm wide, screw-in, flat stock, packaged individually, sterile, disposable, box of 6
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JYO | KNIFE, EAR | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63660 | Tympanotomy knife, single-use | A hand-held, manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00190660197940 | GS1 | BX | 6 | In Commercial Distribution | |
| Primary | 10190660197947 | GS1 |
Customer Contacts
- Phone
- +1(888)407-0006 ext. 0
- [email protected]