FDA UDI
In Commercial Distribution
🇺🇸 United States
Wire Watch™
DI: M710WW12K0
·
Model: WW-12K
·
BIOTEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Wire Watch™
- Primary DI
- M710WW12K0
- Version / Model
- WW-12K
- Company Name
- BIOTEX, INC.
- Labeler DUNS
- 969792050
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-31
- Public Version
- 1
- Public Version Date
- 2023-08-08
- Public Version Status
- New
- Public Device Record Key
- 40c6c5d1-5c5a-44c6-8d4d-19d7c0925029
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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34957 | Surgical drape clip, reusable | A surgical instrument with two blades joined at their midpoint or made from a single alpha-shaped part, designed to temporarily attach or hold a drape(s), or to hold a drape to other devices, during a surgical procedure. It is typically designed with flat gripping blades so as not to harm the material of the drape. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M710WW12K2 | HIBCC | Dispenser | 12 | In Commercial Distribution | |
| Primary | M710WW12K0 | HIBCC | ||||
| Previous | M71002110010 | HIBCC |
Customer Contacts
- Phone
- 7137410111
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius