AccessGUDID - DEVICE: Ambler Surgical (00190660138301)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Kolbel mini open self-retaining retractor set - includes hinged frame
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72-225
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660138301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Kolbel mini open self-retaining retractor set - includes hinged frame, 1 each: 36.0mm, 53.0mm and 68.0mm center blades, 2 each: 20.0mm x 36.0mm blades, 20.0mm x 53.0mm blades and 20.0mm x 68.0mm blades (72-245, 72-256, 72-257, 72-258, 72-265, 72-266 and 72-267)

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a105792-a081-4650-9ca9-1b2599e3bdbe
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021