Sharn Inc BAT1-100

GUDID 00817518020129

PATIENT EYE PROTECTOR 100/CASE

Sharn Anesthesia

Eye patch

• Primary Device ID: 00817518020129
• NIH Device Record Key: 8065d9b6-abeb-4bd7-8d83-72e5e9ede85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sharn Inc
• Version Model Number: BAT1-100
• Catalog Number: BAT1-100
• Company DUNS: 107996118
• Company Name: Sharn Anesthesia
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-325-3671
• Email: mailbox@sharn.com
• Phone: 800-325-3671
• Email: mailbox@sharn.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817518020129 [Primary]
GS1	00817518021652 [Unit of Use]

FDA Product Code

• HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-23
• Device Publish Date: 2018-09-26

On-Brand Devices [Sharn Inc]

• 00817518022161: EyeGard Pediatric
• 00817518022147: EyeGard Sensitive
• 00817518022123: EyeGard Extended Wear
• 00817518022109: EyeGard
• 00817518021911: REUSABLE BP MANUAL CUFF,DBL TB 26-35CM, FEMALE LUER 1/PKG
• 00817518021904: REUSABLE BP MANUAL CUFF,DBL TB 18-26CM, FEMALE LUER 1/PK
• 00817518021881: DISPOS. BP DOUBLE TUBE MQ MARQUETTE 29-38CM ADULT LONG 20PK
• 00817518021867: DISPOSABLE CUFF, NEONATAL, DT 6-11CM, MALE LUER 20/PK
• 00817518021843: DISPOSABLE CUFF, NEONATAL, DT 3-6CM, MALE LUER 20/PK
• 00817518021638: LIGHT CLOUD PRONE POSITIONER 1/PK
• 00817518021621: DISPOSABLE ARMBOARDS-NEONATE 4 1/2inch x 1 3/4inchL 10/PK
• 00817518021614: DISPOSABLE ARMBOARDS-CHLD 5 1/2inch x 3inchL 10/PK
• 00817518021607: DISPOSABLE ARMBOARDS-ADULT 9inch x 4 3/4inchL 10/PK
• 00817518021591: DISPOS INFUSER BAG W/STOPCOCK & PISTON GA, 1000CC 6/PK
• 00817518021584: DISPOS INFUSER BAG W/STOPCOCK AND PISTON GA,500 CC 6/PK
• 00817518021577: DISPOS PRESSURE INFUSER BAG W/ANEROID GA 1000CC (6 PK)
• 00817518021560: DISPOS PRESS INFUSER BAG W/STOPCOCK, 1000 CC 6/PK
• 00817518021553: DISPOS. PRESSURE INFUSER BAG W/ANERIOD GA. 500 CC 6/PK
• 00817518021546: DISPOS PRESS INFUSER BAG W/STOPCOCK,500 CC 6/PK
• 00817518021539: ENDOMASK ELITE,SILICONE REUSE LARYNGEAL MASK,SIZE 2.5
• 00817518021522: FLEXIBLE DISPOS LARYNGEAL MASK, SIZE 2 5/PK
• 00817518021515: LARYNGEAL MASK, SIZE 2.5 1/PK
• 00817518021492: GENERAL PURPOSE PROBE 50/PK 400 SERIES CE STANDARDS
• 00817518021485: GENERAL PURPOSE PROBE 400 SERIES 50/PK
• 00817518021478: METAL FIBER OPTIC DISPOS BLADE MILLER, SZ 0, 1/PK
• 00817518021461: METAL FIBER OPTIC DISPOS BLADE MACINTOSH, SZ 2, 1/PK
• 00817518021454: METAL FIBER OPTIC DISPOS BLADE MACINTOSH, SZ 1, 1/PK
• 00817518021447: FLEX-TIP REINFORCED ENDO TUBES CUFFED 9.5 10/PK
• 00817518021430: FLEX-TIP ET TUBES, LOW PROFILE 9.5 10/PK
• 00817518021423: FLEX-TIP ET TUBES, HIGH VOLUME /LOW PRESS SIZE 10.0 10/PK
• 00817518021409: PVC-FREE GUEDEL AIRWAYS SIZE 3 (9.0) ORANGE 25/PK
• 00817518021393: Moving Line Temperature Indicator
• 00817518021386: Safe-Soak Endo Sponge Flat Sponge/Dispenser Box PK50
• 00817518021379: Safe-Soak Endo Sponge Tubular Sponge/Dispenser Box PK25
• 00817518021362: Soft BiteBlock, Small, Individually Wrapped PK100
• 00817518021355: Soft BiteBlock, Medium, Individually Wrapped PK100
• 00817518021348: Soft BiteBlock, Large, Individually Wrapped PK100
• 00817518021331: Soft BiteBlock, Disposable PK120
• 00817518020655: TOOTH PROTECTORS INDIVIDUAL WRAPPED 50/PK
• 00817518020310: ENDOMASK ELITE,SILICONE REUSE LARYNGEAL MASK,SIZE 5, 5/PK
• 00817518020303: ENDOMASK ELITE, SILICONE REUSE LARYNGEAL MASK,SIZE 4, 5/PK
• 00817518020297: ENDOMASK ELITE,SILICONE REUSE LARYNGEAL MASK,SIZE 3, 5/PK
• 00817518020280: FLEXIBLE DISPOS LARYNGEAL MASK, SIZE 5 5/PK
• 00817518020273: FLEXIBLE DISPOS LARYNGEAL MASK, SIZE 4 5/PK
• 00817518020266: FLEXIBLE DISPOS LARYNGEAL MASK, SIZE 3 5/PK
• 00817518020259: FLEXIBLE DISPOS LARYNGEAL MASK, SIZE 2.5 5/PK
• 00817518020235: GAS SAMPLING LINES, PVC MALE-FEMALE,10',50/PK
• 00817518020129: PATIENT EYE PROTECTOR 100/CASE
• 00817518022383: Twisted Wire Brush, 24.5" x 10mm, Pink Bead
• 00817518022376: Twisted Wire Brush, 24.5" x 7mm, Yellow Bead