AccessGUDID - DEVICE: AESCULAP (04038653142330)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: BT751R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BT751R
Company Name: Aesculap AG

Primary DI Number: 04038653142330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: Abdominal/Intestinal Spatula, 7 7/8", (200 mm), malleable, width: 12 mm, non-sterile, reusable

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?
14367	Vessel depressor	A hand-held manual surgical instrument designed to displace tissue to facilitate examination of the surrounding area during vessel surgery. It is typically a double-ended device, that can be of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working ends slightly angled to improve tissue manipulation and visibility. It is usually made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	RETRACTOR

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: dd990b08-dbe4-4630-9842-6e946ae5627d
Public Version Date: April 29, 2020
Public Version Number: 1
DI Record Publish Date: April 21, 2020