AccessGUDID - DEVICE: Ambler Surgical (00190660080099)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 34-366
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34-366
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660080099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Z-Type hysterectomy (Parametrium) clamp forceps, 14", slightly curved, serrated jaws, offset ring 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?
44538	Hysterectomy forceps, reusable	A hand-held manual surgical instrument intended for the grasping, pulling or compression of the uterus during a hysterectomy (for the removal of the womb and the necessary associated organs). It typically has a scissors-like, self-retaining, design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end can have a variety of blade designs, e.g., straight or curved; some types may have an additional grasping claw at the distal end. The blades are heavily serrated or may have a profiled longitudinal groove to provide extra grip of the organ. Also known as a parametrium clamp or vaginal clamp. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HCZ	FORCEPS, SURGICAL, GYNECOLOGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092840	000

Device Exempt from Premarket Submission: No 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: 66e78189-d4a7-4d41-8932-ebf25d74bea4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016