FDA UDI
In Commercial Distribution
🇺🇸 United States
Batrik Scrub Pads
DI: 00690521011601
·
Model: 60-46050
·
Batrik Medical Manufacturing Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Batrik Scrub Pads
- Primary DI
- 00690521011601
- Version / Model
- 60-46050
- Catalog Number
- 60-46050
- Company Name
- Batrik Medical Manufacturing Inc
- Labeler DUNS
- 243880700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-25
- Public Version
- 2
- Public Version Date
- 2021-07-08
- Public Version Status
- Update
- Public Device Record Key
- 7dc9aedc-f3a3-4ff0-8ffb-57024bf1b194
Device Description
Scrub Pads for Instruments, 4" x 6" (10 cm x 15 cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61965 | Medical device cleaning sponge/set | A hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690521011601 | GS1 |
Customer Contacts
- Phone
- 514-631-7988
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at ambient temprature