FDA UDI
In Commercial Distribution
🇺🇸 United States
E.M Adams co, inc.
DI: 10840200302019
·
Model: 14-3356-1
·
E.M. ADAMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- E.M Adams co, inc.
- Primary DI
- 10840200302019
- Version / Model
- 14-3356-1
- Company Name
- E.M. ADAMS, INC.
- Labeler DUNS
- 001403807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-21
- Public Version
- 1
- Public Version Date
- 2021-05-31
- Public Version Status
- New
- Public Device Record Key
- 068f7a1b-9ff5-4626-884e-32fe57d45b7b
Device Description
SINGLE INSTRUMENT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61478 | Surgical soft-tissue manipulation forceps, scissors-like, single-use | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50840200302000 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 10840200302019 | GS1 | ||||
| Package | 30840200302020 | GS1 | BX | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(772)461-0532
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K812133 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5" X 9" POUCH/ROCHESTER PEAN, CURVED |