Splinter Out

GUDID 00098108000008

MediPoint Holdings LLC

Dermal curette

• Primary Device ID: 00098108000008
• NIH Device Record Key: 28fc3794-93bd-4435-b6d6-7a66d3de7cb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Splinter Out
• Version Model Number: 19950
• Company DUNS: 118797353
• Company Name: MediPoint Holdings LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00098108000008 [Unit of Use]
GS1	00098108000022 [Primary]
GS1	00098108199054 [Primary]
GS1	00098108199061 [Primary]
GS1	00098108199078 [Primary]
GS1	00098108199559 [Primary]
GS1	00738743224109 [Primary]
GS1	00843484122499 [Primary]
GS1	00843484122505 [Primary]

FDA Product Code

• HTF: Curette

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-06
• Device Publish Date: 2023-03-29

Devices Manufactured by MediPoint Holdings LLC

• 00000981080008 - Hart Medical - Normed - Splinter Out: 2023-10-09
• 00098108000008 - Splinter Out: 2023-04-06
• 00098108000008 - Splinter Out: 2023-04-06
• 00098108195711 - Medipoint Blood Lancets: 2023-02-09
• 00098108195728 - Medipoint Blood Lancets: 2023-02-09
• 00098108000015 - Medipoint: 2022-10-24