AccessGUDID - DEVICE: Ambler Surgical (00190660069339)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Prestige grasping forceps
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 97-408
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660069339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Prestige grasping forceps, rotatable, double-action, 5.0mm diameter, 330.0mm working length, long, atraumatic, wave shaped, straight tips, deep cup, lateral serrated jaws, carbon fiber ring handle with ratchet, HF connection

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?
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	FORCEPS, GENERAL & PLASTIC SURGERY

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: d0a52e46-f814-4748-a41c-a64f33d694d1
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021