AccessGUDID - DEVICE: Ambler Surgical (00190660051822)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 30-205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-205
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660051822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Duplay uterine tenaculum forceps, 10", curved shanks, curved jaws, 1x1 teeth, 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?
35804	Uterine clamp	A scissors-like, hand-held manual surgical instrument designed to grasp and/or manipulate the uterus during surgery. It is typically made of high-grade stainless steel and will have wide, rounded, blades at the distal end to hold the uterus during a surgical intervention. 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: 10000490-4829-40b4-9696-045e0f22f009
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016