AccessGUDID - DEVICE: Ambler Surgical (00190660110130)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Desjardin gall stone scoop
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44-871
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660110130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Desjardin gall stone scoop, 11'', malleable, size #1, 18 French

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?
63259	Dermal curette	A sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHL	SCOOP

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: a1efbf83-5a07-48e8-ac8f-740b560a35ea
Public Version Date: January 15, 2021
Public Version Number: 1
DI Record Publish Date: January 07, 2021