FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROMAT®
DI: 00650551037576
·
Model: 3103-3G
·
PMT CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICROMAT®
- Primary DI
- 00650551037576
- Version / Model
- 3103-3G
- Catalog Number
- 3103-3G
- Company Name
- PMT CORPORATION
- Labeler DUNS
- 039576871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-05-23
- Public Version Status
- Update
- Public Device Record Key
- 0bf10b44-3097-4d35-8fca-ab82de473d7d
Device Description
MICROSURGICAL GRID WITH SUCTION - BLUE BACKGROUND
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
| FNW | Pad, Kelly | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38566 | Surgical capillary wound drain, non-luminal | A sterile device, without a lumen, designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically available as a corrugated drainage sheet or ribbon made of non-latex materials [e.g., polyvinyl chloride (PVC), silicone], and may include radiopaque markers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00650551037576 | GS1 | ||||
| Package | 00650551037583 | GS1 | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-626-5463
- [email protected]
- Phone
- 800-626-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 3 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 58 – 78 Degrees Fahrenheit