AccessGUDID - DEVICE: Bone Cement Delivery Gun (15060238201848)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Cement Delivery Gun
Version or Model: H719
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H719
Company Name: SUMMIT MEDICAL LIMITED

Primary DI Number: 15060238201848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221751311 *Terms of Use

Device Description: Bone Cement Delivery Gun

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?
47703	Orthopaedic cement/bone filler dispensing gun	A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: 9a826336-f333-42b8-a279-7e4d5c3bee3e
Public Version Date: January 20, 2025
Public Version Number: 1
DI Record Publish Date: January 10, 2025

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: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +441451821311
Email: info@summit-medical.co.uk

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