AccessGUDID - DEVICE: Batrik Non-Sterile Red Clamp Jaw Cover (00690521013827)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Non-Sterile Red Clamp Jaw Cover
Version or Model: 912-1000-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 912-1000-100
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521013827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Clamp Jaw Covers, Radio Opaque, Non-Sterile, Red, 0.1"" x 5"" / 0.25cm x 12.7 cm

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?
43387	Clamp jaw cover, non-sterile	A non-sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. Sterilization takes place along with the instrument prior to the procedure. It may also be known as jaw covers. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HCF	Instrument, Ligature Passing And Knot Tying

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: 3703ae13-0451-43f2-92f2-5b2fc0e59b90
Public Version Date: November 05, 2021
Public Version Number: 1
DI Record Publish Date: October 28, 2021