AccessGUDID - DEVICE: KMEDIC (24026704268317)

GUDID

Device Identifier (DI) Information

Brand Name: KMEDIC
Version or Model: IPN013640
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KM46090
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 24026704268317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: BRUNS SHEARS 9 1/4"

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?
46314	Cast cutting scissors	A hand-held surgical instrument with specially strong, curved blades that is used to cut small plaster cast dressings and layers of thick material, e.g., bandages. It is designed like a strong pair of scissors with two pivoted blades usually provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded or have a pod at the tip for safety. The longest blade is inserted between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create the cutting effect. It is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGG	INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

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
Length: 23.8 Centimeter

Device Record Status

Public Device Record Key: 2b711f83-88e4-4fa4-abe7-1a9cbfcd0e92
Public Version Date: December 16, 2019
Public Version Number: 2
DI Record Publish Date: September 15, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: Yes
DM DI Number: 04026704268313
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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