AccessGUDID - DEVICE: Ambler Surgical (00190660029500)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Bakes common bile duct dilators
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 43-915
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660029500
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Bakes common bile duct dilators, 9'', set of 9, sizes 3.0mm - 11.0mm (43-903, 43-904. 43-905. 43-906, 43-907, 43-908, 43-909, 43-910 and 43-911)

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?
14286	Urethral bougie, reusable	A rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFP	DILATOR, RECTAL

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: e9cc9774-27ba-46f9-a45e-aadec27f65df
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021