Unipack UBE-8050

GUDID 20665973029416

PSP Barrier Envelopes Top Opening Size 0

UNIPACK MEDICAL CORPORATION

Digital imaging cassette/storage phosphor screen, dental

• Primary Device ID: 20665973029416
• NIH Device Record Key: 51ef0a2b-1902-470f-8c20-3db3605a969a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unipack
• Version Model Number: UBE-8050
• Catalog Number: UBE-8050
• Company DUNS: 018319397
• Company Name: UNIPACK MEDICAL CORPORATION
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00665973029412 [Unit of Use]
GS1	10665973029419 [Primary]
GS1	20665973029416 [Package]; Contains: 10665973029419; Package: Case [36 Units]; In Commercial Distribution

FDA Product Code

• NRD: Unit, operative dental, accessories

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Unipack]

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• D784UTT10015: Clip Cord Covers 2" x 1200' BlackCat
• D784UST90755: Aspirator Tips Blue 1/16" x 7-1/4"
• D784UST90745: Aspirator Tips Green 1/4" x 6-1/4"
• D784UST90735: Aspirator Tips White 1/8" x 6-1/4"
• D784URS559005: Impression Syringes 5ml
• D784URS551125: Utility Syringes Curved 12cc
• D784URN553305: Irrigation Probes 30G Side Port Blue Hub/Luer Lock
• D784URN553275: Irrigation Probes 27G Side Port Blue Hub/Luer Lock
• D784URN553235: Irrigation Probes 23G Side Port Blue Hub/Luer Lock
• D784URN552305: Irrigation Needle Tips 30G Notched Blue/Luer Lock
• D784URN552275: Irrigation Needle Tips 73G Notched Blue/Luer Lock
• D784URN55225B5: Pre-Bent Dispensing Tips 25 Gauge Blue
• D784URN552235: Irrigation Needle Tips 23G Notched Blue/Luer Lock
• D784URN55222G5: Pre-Bent Dispensing Tips 22 Gauge Gray
• D784URN55220Y5: Pre-Bent Dispensing Tips 20 Gauge Yellow
• D784URN55220K5: Pre-Bent Dispensing Tips 20 Gauge Black
• D784URN55218P5: Pre-Bent Dispensing Tips 18 Gauge Pink
• D784URN55103305: Combo Syringe 30G Side Port Blue/3cc Luer Lock
• D784URN55103275: Combo Syringe 27G Side Port Blue/3cc Luer Lock
• D784URN55103235: Combo Syringe 23G Side Port Blue/3cc Luer Lock
• D784URN55003305: Combo Syringe 30G Notched Blue/3cc Luer Lock
• D784URN55003275: Combo Syringe 27G Notched Blue/3cc Luer Lock
• D784URN55003235: Combo Syringe 23G Notched Blue/3cc Luer Lock
• D784UPT0065: Sterilization Tubing 6" x 100'
• D784UPT0045: Sterilization Tubing 4" x 100'
• D784UPT0035: Sterilization Tubing 3" x 100'
• D784UPT0025: Sterilization Tubing 2" x 100'
• D784UPST1005: Sterilization Tape Steam 1" x 60 yards
• D784UPST0755: Sterilization Tape Steam 3/4" x 60 yards
• D784UPST0505: Sterilization Tape Steam 1/2" x 60 yards
• D784UNW40225: Non-Woven Sponges Premium 2" x 2", Non-Sterile
• D784UNW35225: Non-Woven Sponges Eco Plus 2" x 2", Non-Sterile
• D784UNW30445: Non-Woven Sponges 4" x 4", Non-Sterile
• D784UNW30335: Non-Woven Sponges 3" x 3", Non-Sterile
• D784UMA9119SW5: Micro Applicators Super Fine White
• D784UMA9118FA5: Micro Applicators Fine Assorted
• D784UMA9117FP5: Micro Applicators Fine Pink
• D784UMA9116FY5: Micro Applicators Fine Yellow
• D784UMA9115RA5: Micro Applicators Regular Assorted
• D784UMA9114RP5: Micro Applicators Regular Purple
• D784UMA9113RO5: Micro Applicators Regular Orange/Peach
• D784UMA9112RG5: Micro Applicators Regular Green
• D784UMA9111RB5: Micro Applicators Regular Blue
• D784UMA9014XS5: Micro Applicators Extra Slim Black
• D784UBE81625: SLDR PSP BARRIER ENVELOPES Size 2
• D784UBE81615: SLDR PSP BARRIER ENVELOPES Size 1
• D784UBE81605: SLDR PSP BARRIER ENVELOPES Size 0
• D784UBC8HVE5: HVE Screenss 8HVE Universal Fit
• D784UBC86400C5: Evacuation Traps 86400C Diameter 1-5/8"