FDA UDI
In Commercial Distribution
🇺🇸 United States
Collection Bags, M3000, Pack 10
DI: 00850039020278
·
Model: 551-0067-001
·
Medical Technical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Collection Bags, M3000, Pack 10
- Primary DI
- 00850039020278
- Version / Model
- 551-0067-001
- Company Name
- Medical Technical Products, Inc.
- Labeler DUNS
- 151291010
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-14
- Public Version
- 1
- Public Version Date
- 2023-02-22
- Public Version Status
- New
- Public Device Record Key
- 93158853-014a-445b-a9e0-c8f0743bd781
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63972 | Ophthalmic surgery fluid collection bag | A non-sterile synthetic polymer bag intended to be used to collect aspirated materials (e.g., irrigation solution, vitreous humour, blood) from the eye during an ophthalmic surgical procedure, typically phacoemulsification/vitrectomy. It is connected to the surgical system drain port via tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850039020278 | GS1 |
Customer Contacts
- Phone
- +1(949)551-4762
- [email protected]