FDA UDI
In Commercial Distribution
🇺🇸 United States
Applier 30cm
DI: M660AP030A0
·
Model: AP030A
·
VIRTUAL PORTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Applier 30cm
- Primary DI
- M660AP030A0
- Version / Model
- AP030A
- Catalog Number
- AP030A
- Company Name
- VIRTUAL PORTS LTD
- Labeler DUNS
- 514870547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-23
- Public Version
- 1
- Public Version Date
- 2021-07-01
- Public Version Status
- New
- Public Device Record Key
- 59f2771e-7645-4b84-afa8-f44cba7ddad2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58097 | Internally-anchored endoscopic retractor applier | A non-sterile, hand-held, manually-operated surgical instrument designed to perform through a compatible endoscopic instrument (e.g., an access port) to insert, manipulate, and activate (apply) an internally-anchored endoscopic retractor to provide hands-free retraction of a selected internal organ. It typically consists of a pistol-like device with a long, thin, insertion portion and a distal tip that can interface a variety of devices; it also includes an interchangeable tubular sleeve for retractor insertion. The applier is also intended to extract the retractor after completion of the procedure. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M660AP030A0 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius