FDA UDI
In Commercial Distribution
🇺🇸 United States
E.M. Adams Co, Inc.
DI: 10840200325537
·
Model: 14-3497-1
·
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
- 10840200325537
- Version / Model
- 14-3497-1
- Company Name
- E.M. ADAMS, INC.
- Labeler DUNS
- 001403807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-20
- Public Version
- 1
- Public Version Date
- 2023-10-30
- Public Version Status
- New
- Public Device Record Key
- 1a80655e-d305-4d3b-a911-b36a35daef1b
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
- 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 |
|---|---|---|---|---|
| 63658 | Surgical soft-tissue manipulation forceps, alligator, single-use | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures, typically during ear/nose/throat (ENT) surgery; it is not intended for insertion through an endoscope, nor into the eye and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50840200325528 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 10840200325537 | GS1 |
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/ALLIGATOR FORCEPS |