FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PROLITE
DI: 00650862301014
·
Model: 1010101-01
·
Atrium Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PROLITE
- Primary DI
- 00650862301014
- Version / Model
- 1010101-01
- Company Name
- Atrium Medical Corporation
- Labeler DUNS
- 051798999
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 9
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 0c2ff1ff-f968-4599-8494-a9ce4345dad0
- Distribution End Date
- 2019-12-31
Device Description
ProLite Mesh S, 1.0in. x 2in. (2.5cm x 5cm), 4in. (10cm)
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
- No
- MRI Safety
- MR Safe
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60300 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable | An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polycarbonate (PC), carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20650862301018 | GS1 | 5 | Not in Commercial Distribution | 2019-12-31 | |
| Primary | 00650862301014 | GS1 |