FDA UDI
In Commercial Distribution
🇺🇸 United States
PRO-PAKS®️
DI: 10810003220292
·
Model: PD850A
·
MICROSPECIALITIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PRO-PAKS®️
- Primary DI
- 10810003220292
- Version / Model
- PD850A
- Catalog Number
- PD850A
- Company Name
- MICROSPECIALITIES, INC.
- Labeler DUNS
- 013469890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-30
- Public Version
- 1
- Public Version Date
- 2018-11-30
- Public Version Status
- New
- Public Device Record Key
- c9de1661-5e07-4f05-ada1-79fc714780ee
Device Description
Drape Full Body N-W, SMS, Aperture and Pouches. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our drapes. 10 per bag.
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HMT | Drape, Patient, Ophthalmic | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46697 | Ophthalmic surgical drape | A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30810003220296 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10810003220292 | GS1 |
Customer Contacts
- Phone
- 203-874-1832
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 71 | Inch | |
| Length | 100 | Inch | |
| Width | 180.34 | Centimeter | |
| Length | 254 | Centimeter |