ONE 17508X10

GUDID 03700483620456

MORIA SA

Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use Eyelid speculum, single-use

• Primary Device ID: 03700483620456
• NIH Device Record Key: 7e5cb607-4731-4c8b-a1b5-ffa41b49f138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE
• Version Model Number: One S-adj speculum with swivels x10
• Catalog Number: 17508X10
• Company DUNS: 275937506
• Company Name: MORIA SA
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700483620432 [Primary]
GS1	03700483620456 [Package]; Contains: 03700483620432; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• HNC: Specula, Ophthalmic

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: 2024-01-08
• Device Publish Date: 2023-12-29

On-Brand Devices [ONE]

• 03700483603329: ONE - Punch D9.50mm x1
• 03700483600175: ONE - Punch D9.00mm x1
• 03700483600168: ONE - Punch D8.75mm x1
• 03700483600151: ONE - Punch D8.50mm x1
• 03700483600144: ONE - Punch D8.25mm x1
• 03700483600137: ONE - Punch D8.00mm x1
• 03700483603312: ONE - Punch D7.75mm x1
• 03700483603305: ONE - Punch D7.50mm x1
• 03700483603299: ONE - Punch D7.25mm x1
• 03700483603282: ONE - Punch D7.00mm x1
• 03700483603855: ONE - Punch D6.75mm x1
• 03700483603848: ONE - Punch D6.50mm x1
• 03700483603831: ONE - Punch D6.00mm x1
• 03700483625864: XS PEDIATRIC WIRE SPECULUM
• 03700483625826: ROP KIT S SPECULUM/LOOP DEPRESSOR
• 03700483625789: ROP KIT XS SPECULUM/LOOP DEPRESSOR
• 03700483625741: ROP KIT XS SPECULUM/2IN1 DEPRESSOR
• 03700483627141: ROP KIT XS SPECULUM/2IN1 DEPRESSOR
• 03700483624812: ONE-DEEP WELL FULL CUT D10.00MM X 1
• 03700483624775: ONE-DEEP WELL FULL CUT D9.50MM X 1
• 03700483624737: ONE-DEEP WELL FULL CUT D9.00MM X 1
• 03700483624690: ONE-DEEP WELL FULL CUT D8.75MM X 1
• 03700483624652: ONE-DEEP WELL FULL CUT D8.50MM X 1
• 03700483624614: ONE-DEEP WELL FULL CUT D8.25MM X 1
• 03700483624577: ONE-DEEP WELL FULL CUT D8.00MM X 1
• 03700483624539: ONE-DEEP WELL FULL CUT D7.75MM X 1
• 03700483624492: ONE-DEEP WELL FULL CUT D7.50MM X 1
• 03700483624454: ONE-DEEP WELL FULL CUT D7.25MM X 1
• 03700483624416: ONE-DEEP WELL FULL CUT D7.00MM X 1
• 03700483624379: ONE-DEEP WELL FULL CUT D6.75MM X 1
• 03700483624331: ONE-DEEP WELL FULL CUT D6.50MM X 1
• 03700483624294: ONE-DEEP WELL FULL CUT D6.00MM X 1
• 03700483624256: ONE-DEEP WELL GUARDED COVER D8.00MM X 1
• 03700483624218: ONE-DEEP WELL GUARDED COVER D7.75MM X 1
• 03700483624171: ONE-DEEP WELL GUARDED COVER D7.50MM X 1
• 03700483624133: ONE-DEEP WELL TRI-FOLD COVER R8.00MM X 1
• 03700483624096: ONE-DEEP WELL TRI-FOLD COVER R7.75MM X 1
• 03700483624058: ONE-DEEP WELL TRI-FOLD COVER R7.50MM X 1
• 03700483622573: ONE-SIEBEL MANIPULATOR X10
• 03700483622535: ONE-LESTER MANIP. STRAIGHT X10
• 03700483620265: One S-flat tying forceps curved x10
• 03700483620234: One S-flat tying forceps angled x10
• 03700483620180: One-pediatric wire speculum x10
• 03700483620166: ROP exam kit W/WS -L x10
• 03700483620227: One S-flat tying forceps angled x5
• 03700483603459: ONE - ROP EXAM. KIT - L
• 03700483602230: ONE-BORES MARKER, 12MM
• 03700483602223: ONE-BORES MARKER, 12MM
• 03700483602216: ONE-MENDEZ RING, 12MM
• 03700483602193: ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL