FDA UDI
In Commercial Distribution
🇺🇸 United States
American Medicals
DI: B356111PL86414ST0
·
Model: 1
·
American Medicals
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- American Medicals
- Primary DI
- B356111PL86414ST0
- Version / Model
- 1
- Company Name
- American Medicals
- Labeler DUNS
- 109909627
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-09
- Public Version
- 3
- Public Version Date
- 2023-09-29
- Public Version Status
- Update
- Public Device Record Key
- ca8b8949-dc95-43e3-a202-e6194e7f361f
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
- 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 |
|---|---|---|---|---|
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64971 | General surgery wound probe/packer | A slender, double-ended, hand-held manual surgical instrument intended to be used to explore and examine wounds, and additionally to introduce and pack gauze or dressings into the wound. It consists of a flat blunt blade at one end and a packer at the other end, with the handle formed from its middle section; it is made of metallic and/or synthetic polymer material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B356111PL86414ST0 | HIBCC | ||||
| Package | B356111PL86414ST1 | HIBCC | 25 | In Commercial Distribution |