AccessGUDID - DEVICE: Ambler Surgical (00190660133160)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 70-816
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-816
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660133160
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: B-Z Weitlaner retractor, offset arms, angled 90º, 2 1/2" deep right arm, 5" deep left arm, 4x4 blunt prongs, ring handle with lock

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?
13384	Laminectomy retractor, self-retaining	A self-locking, surgical instrument, used for separating the edges or drawing aside the margins of a surgical incision to permit excision of the lamina of the vertebral posterior arch; this can be necessary to expose a portion of the spinal cord for removal of a tumour, relief of pressure due to a fracture, or disc protrusion. The instrument may resemble a large pair of scissors with wide-angle blades which have fenestrated curved hooks, often terminating in sharp points, at the distal end to grasp the tissues. It is usually made of stainless steel and comes in a variety of designs. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GZT	RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071771	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: a967bc6b-2715-4440-b933-4024e455ccd3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016