FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Punch, 6.5 mm
DI: 00818614022598
·
Model: 00-65P
·
Maruho Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Punch, 6.5 mm
- Primary DI
- 00818614022598
- Version / Model
- 00-65P
- Company Name
- Maruho Medical, Inc.
- Labeler DUNS
- 117630237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-15
- Public Version
- 1
- Public Version Date
- 2022-09-23
- Public Version Status
- New
- Public Device Record Key
- bc988075-5d10-4aab-be8f-c136d027d04d
Device Description
Disposable Punch, 6.5 mm Pouch
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 |
|---|---|---|---|---|
| LRY | Punch, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64336 | Bone-coring punch, single-use | A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818614022595 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00818614022598 | GS1 |