AccessGUDID - DEVICE: Batrik Non-Sterile Suture Tags White (00690521011069)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Non-Sterile Suture Tags White
Version or Model: 911-1045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 911-1045
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521011069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: "Suture Clamp Tags, Radio Opaque, Non-Sterile, White, Standard ø 0.06"" x 0.5""L"

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
13895	Operative-site suture holder	A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDC	Instrument, Surgical, Disposable

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7fba7f8-393f-44a6-a8a2-cf9666d7d3a4
Public Version Date: November 05, 2021
Public Version Number: 1
DI Record Publish Date: October 28, 2021