AccessGUDID - DEVICE: CSU BALFOUR RETRACTOR (00192896097810)

GUDID

Device Identifier (DI) Information

Brand Name: CSU BALFOUR RETRACTOR
Version or Model: 1100-611C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1100-611C
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896097810
Issuing Agency: GS1
Commercial Distribution End Date: November 25, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: CSU BALFOUR RETRACTOR DOUBLE BAR WITH EXTRA LARGE BLADES

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:	No
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?
45182	Self-retaining surgical retractor, reusable	A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFO	Retractor, Self-Retaining

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7 Inch

Device Record Status

Public Device Record Key: 8bd39402-0435-42a0-8e45-d8e6ce5b0d30
Public Version Date: November 26, 2019
Public Version Number: 3
DI Record Publish Date: June 18, 2019