FDA UDI
In Commercial Distribution
🇺🇸 United States
ADEPT MEDICAL
DI: M6333814000
·
Model: 38-1400
·
JEDMED INSTRUMENT COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ADEPT MEDICAL
- Primary DI
- M6333814000
- Version / Model
- 38-1400
- Catalog Number
- 38-1400
- Company Name
- JEDMED INSTRUMENT COMPANY
- Labeler DUNS
- 092987189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 2
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 4de9a390-67b1-4bc3-8c10-555df8b28c51
Device Description
MYRINGOTOMY KNIFE STERILE
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| JYP | Knife, Myringotomy | 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 |
|---|---|---|---|---|---|---|
| Primary | M6333814000 | HIBCC |