RIGISTER CUPULE 35 mm

GUDID 03700111401129

Device for hysterosalpingography and chromopertubation

LABORATOIRE CCD

Intrauterine imaging medium catheterization kit

• Primary Device ID: 03700111401129
• NIH Device Record Key: ccdd7cae-32d5-4675-a782-f4882e9514d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGISTER CUPULE 35 mm
• Version Model Number: RIGISTER CUPULE 35 mm
• Company DUNS: 381633924
• Company Name: LABORATOIRE CCD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700111401129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894259

FDA Product Code

• HIG: Insufflator, Hysteroscopic

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: 2025-12-05
• Device Publish Date: 2025-11-27

Devices Manufactured by LABORATOIRE CCD

• 03700111401099 - RIGISTER CUPULE 20 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401105 - RIGISTER CUPULE 25 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401112 - RIGISTER CUPULE 30 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401129 - RIGISTER CUPULE 35 mm: 2025-12-05Device for hysterosalpingography and chromopertubation
• 03700111401129 - RIGISTER CUPULE 35 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401136 - SLIDING RIGISTER CUPULE 20 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401143 - SLIDING RIGISTER CUPULE 25 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401150 - SLIDING RIGISTER CUPULE 30 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation
• 03700111401167 - SLIDING RIGISTER CUPULE 35 mm: 2025-12-05 Device for hysterosalpingography and chromopertubation