AccessGUDID - DEVICE: Ambler Surgical (00190660110055)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Joseph nasal bone saw
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44-840
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660110055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Joseph nasal bone saw, 5 1/8'', heavy, angled left, 35.0mm blade, flat 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?
44983	Manual surgical saw blade, rigid	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a rigid manual hand saw used for cutting bone/tissue when a directional pressure is applied. This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is manually powered in a back and forth motion by the user. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDR	SAW, MANUAL AND ACCESSORIES

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: 3d11169f-8152-47d1-b71c-7743303f680f
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021