AccessGUDID - DEVICE: SUSI (04038653386277)

GUDID

Device Identifier (DI) Information

Brand Name: SUSI
Version or Model: BD557SU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BD557SU
Company Name: Aesculap AG

Primary DI Number: 04038653386277
Issuing Agency: GS1
Commercial Distribution End Date: October 26, 2021
Device Count: 20
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: SUSI Tissue Forceps, 5 3/4", (145 mm), toothed (1x2), sterile, disposable, pack of 20 pcs, single packed

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:	Yes
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?
62479	Surgical soft-tissue manipulation forceps, tweezers-like, single-use	A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	FORCEPS

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: fba50197-c10e-4ae1-a280-612786f4d689
Public Version Date: January 19, 2022
Public Version Number: 2
DI Record Publish Date: May 21, 2020