AccessGUDID - DEVICE: Instrument (05060296233853)

GUDID

Device Identifier (DI) Information

Brand Name: Instrument
Version or Model: impbimp/Std
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IMPBIMP-STD
Company Name: Stanmore Implants Worldwide Ltd

Primary DI Number: 05060296233853
Issuing Agency: GS1
Commercial Distribution End Date: June 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 494989502 *Terms of Use

Device Description: Plastic Tibial Bearing Impactor: Standard

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?
32856	Orthopaedic implant impactor, reusable	A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092138	000
K133152	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: e52a99fb-188b-4b9b-8475-ae56a2fae8bd
Public Version Date: June 05, 2023
Public Version Number: 3
DI Record Publish Date: July 18, 2019