AccessGUDID - DEVICE: Ambler Surgical (00190660133696)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 71-112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-112
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660133696
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Contour self-retaining scalp retractor, 5 1/2", straight, 3x4 blunt prongs, ring handle with ratchet, titanium

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?
32560	Neurosurgical retractor, self-retaining	A surgical instrument for separating and/or drawing aside nervous system structures or other tissues to permit examination or intervention. Once set, this retractor maintains its set position. It is made of high-grade stainless steel. 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: 6c46b78b-c7dc-486c-9421-350af84230c0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016