DENVER SPLINT

GUDID 10385640048986

SUMMIT MEDICAL, INC.

External nasal splint

• Primary Device ID: 10385640048986
• NIH Device Record Key: 27dd8661-f4eb-452e-b60d-c0f49835536c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENVER SPLINT
• Version Model Number: 10-4021-05KS
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640048989 [Primary]
GS1	10385640048986 [Package]; Contains: 00385640048989; Package: BOX [5 Units]; In Commercial Distribution

FDA Product Code

• EPP: Splint, Nasal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [DENVER SPLINT]

• 10385640049266: 10-4022-10NKL
• 10385640049235: 10-4022-10NKM
• 10385640048931: 10-4021-10NKP
• 10385640048917: 10-4022-05KL
• 10385640048900: 10-4022-05KS
• 10385640048894: 10-4022-05KP
• 10385640049228: 10-4031-10NKL
• 10385640049211: 10-4031-10NKS
• 10385640049204: 10-4031-10NKP
• 10385640049198: 10-4031-10NKM
• 10385640049174: 10-4032-05KL
• 10385640049143: 10-4032-05KM
• 10385640048948: 10-4021-10NKS
• 10385640048887: 10-4022-05KM
• 10385640052969: 10-1500-05KS
• 10385640052945: 10-1500-05KP
• 10385640052938: 10-1500-05KM
• 10385640052921: 10-1500-05KL
• 10385640048993: 10-4021-05KL
• 10385640048986: 10-4021-05KS
• 10385640048979: 10-4021-05KP
• 10385640048962: 10-4021-05KM
• 10385640053003: 10-1500-10NKS
• 10385640052990: 10-1500-10NKP
• 10385640052983: 10-1500-10NKM
• 10385640052976: 10-1500-10NKL
• 10385640048955: 10-4021-10NKL
• 10385640048924: 10-4021-10NKM
• 10385640065792: 10-4021-10NKM
• 00385640086769: 10-4022-05KS-C
• 00385640086752: 10-4022-05KL-C
• 00385640086745: 10-4021-05KS-C
• 00385640086738: 10-4021-05KL-C
• 00385640086721: 10-1500-05KS-C
• 00385640086714: 10-1500-05KP-C
• 00385640086707: 10-1500-05KM-C
• 00385640086691: 10-1500-05KL-C