AccessGUDID - DEVICE: Ambler Surgical (00190660083441)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Austin foot plate hook
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 37-126
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660083441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Austin foot plate hook, 6 1/4'', straight shaft, angled 90 degrees, 0.50mm long tip, round handle

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?
13039	Middle ear pick	A fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYL	HOOK, MICROSURGICAL EAR

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: 647892fb-537a-4f5e-b4ee-aafc943fe7f4
Public Version Date: January 15, 2021
Public Version Number: 1
DI Record Publish Date: January 07, 2021