FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E.M. Adams, Inc.
DI: B1211460108
·
Model: 14 60108
·
E.M. ADAMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- E.M. Adams, Inc.
- Primary DI
- B1211460108
- Version / Model
- 14 60108
- Company Name
- E.M. ADAMS, INC.
- Labeler DUNS
- 001403807
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-18
- Public Version
- 3
- Public Version Date
- 2021-06-21
- Public Version Status
- Update
- Public Device Record Key
- fe5d7609-8ae9-433b-b519-4c56dbf380fd
- Distribution End Date
- 2021-06-18
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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHG | Circumcision Tray | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34945 | Circumcision kit, single-use | A collection of sterile devices designed to perform a circumcision procedure. It typically includes a disinfectant, circumcision clamp, scissors, and a scalpel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1211460108 | HIBCC |