AccessGUDID - DEVICE: Wire Watch™ (M710WW1D0)

GUDID

Device Identifier (DI) Information

Brand Name: Wire Watch™
Version or Model: WW-1D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTEX, INC.

Primary DI Number: M710WW1D0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969792050 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGZ	Accessories, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 657b0c36-5de5-4aff-a81a-2aae1fe75fb0
Public Version Date: July 11, 2024
Public Version Number: 1
DI Record Publish Date: July 03, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M710WW1D30PK2	30	M710WW1D0		In Commercial Distribution	Dispenser

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 7137410111
Email: xx@xx.xx

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