FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E.M Adams co, inc.
DI: 18100013401876
·
Model: 14-3345-1
·
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
- 18100013401876
- Version / Model
- 14-3345-1
- 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
- 2019-12-31
- Public Version
- 3
- Public Version Date
- 2021-03-01
- Public Version Status
- Update
- Public Device Record Key
- c368fa9c-91be-4bed-b8d3-5a85e7985d36
- Distribution End Date
- 2021-02-28
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 | 38100013401887 | GS1 | BX | 20 | Not in Commercial Distribution | 2021-02-28 |
| Primary | 18100013401876 | GS1 | ||||
| Package | 58100013401867 | GS1 | Case | 100 | Not in Commercial Distribution | 2021-02-28 |
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" X9" POUCH/ROCHESTER PEAN, STRAIGHT |