AccessGUDID - DEVICE: Tube Cutter (14063107101745)

GUDID

Device Identifier (DI) Information

Brand Name: Tube Cutter
Version or Model: CK1022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CK1022
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107101745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
46531	Paper/plastic sheet guillotine	A manually-operated cutting device designed to cut or trim sheets of paper or thin plastic (e.g., transparency film, or x-ray film) into a desired size. It is typically made up of a metal frame on a base that has a pivoted cutting blade with a handle that is attached and operated by the user. Moving the handle/blade in a downward movement, this cuts the object(s) that have been placed on the base as it passes a stationary blade that is fastened to the base. It is made of plastic and metal, high-grade stainless steel for the blades, and is available in various shapes and sizes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNS	Ring Cutter

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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22c7c70d-29e7-4043-bb16-4b4a35099348
Public Version Date: September 08, 2022
Public Version Number: 1
DI Record Publish Date: August 31, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
34063107101749	1	14063107101745		In Commercial Distribution	Carton

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: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 1-800-433-2674
Email: info@bosmed.com

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