FDA UDI
In Commercial Distribution
🇺🇸 United States
E.M. Adams Co, Inc
DI: 10840200325575
·
Model: 114-A3609-1
·
E.M. ADAMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- E.M. Adams Co, Inc
- Primary DI
- 10840200325575
- Version / Model
- 114-A3609-1
- Company Name
- E.M. ADAMS, INC.
- Labeler DUNS
- 001403807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-17
- Public Version
- 1
- Public Version Date
- 2023-11-27
- Public Version Status
- New
- Public Device Record Key
- 91adbffd-0f77-495f-8f17-09ff2c0e9f09
Device Description
Laceration Tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 56303 | Suture kit, non-medicated | A collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50840200325566 | GS1 | case | 20 | In Commercial Distribution | |
| Primary | 10840200325575 | GS1 |
Customer Contacts
- Phone
- +7724610532
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K812133 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8.75" X 7" X 1.25" |