AccessGUDID - DEVICE: Ambler Surgical (00190660106188)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Steinmann pin chuck
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 43-790
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660106188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Steinmann pin chuck, 4'', fully cannulated, includes chuck key

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:	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?
31048	Surgical drill chuck	A device designed to grip a cutting tool (normally a drill bit or other rotational cutting tool) using three adjustable jaws that are geared to be manually closed concentrically upon the cutting tool. It is attached (locked) to a surgical drilling machine which is usually powered, but may be manual. A special key is often used to close and tighten the jaws. Commonly known as a Jacobs chuck, it is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: d53f9858-8153-4e72-8757-8ff2e89ff6ea
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021