FDA UDI
In Commercial Distribution
🇺🇸 United States
EDM3
DI: M202BP601
·
Model: BP60
·
EDM 3, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- EDM3
- Primary DI
- M202BP601
- Version / Model
- BP60
- Catalog Number
- BP60
- Company Name
- EDM 3, LLC
- Labeler DUNS
- 042497900
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- 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
- aa5b0e23-0132-40a1-8d3e-0f8178d8ea95
Device Description
Biopsy punches, sterile, 6.0mm, light green.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63166 | Skin-coring punch, single-use | A hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically made of high-grade stainless steel and is available in various cutting head sizes; it is not a biopsy gun. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | M202BP600 | HIBCC | ||||
| Primary | M202BP601 | HIBCC |
Customer Contacts
- Phone
- 904-996-7758
- [email protected]