Cefla 97901113

GUDID 08717228442766

Hygienic Sheaths for sensor Size 1

DuPhaMed B.V.

Medical equipment drape, single-use

• Primary Device ID: 08717228442766
• NIH Device Record Key: 60d035f0-7ffc-4235-9be1-139d4b8ef6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cefla
• Version Model Number: CEFS01
• Catalog Number: 97901113
• Company DUNS: 413491023
• Company Name: DuPhaMed B.V.
• Device Count: 500
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717228440137 [Primary]
GS1	08717228440427 [Primary]
GS1	08717228442766 [Unit of Use]

FDA Product Code

• EGZ: Holder, Film, X-Ray

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: 2023-12-01
• Device Publish Date: 2023-11-23

On-Brand Devices [Cefla]

• 08717228442803: Short band for headrest 58 cm in length
• 08717228442797: Short band for headrest 52 cm in length
• 08717228441790: Clip for Phosphor Plate Holder
• 08717228442780: Foam Bites, Cushion inserts for biteblock
• 08717228440441: Phosphor Plate Holder Introduction Pack, content: 2x bitewing - UDI 08717228440243 2x posterior
• 08717228442773: Hygienic Sheaths for sensor Size 2
• 08717228442766: Hygienic Sheaths for sensor Size 1
• 08717228442759: Hygienic Sheaths for biteblock
• 08717228442742: Hygienic Phosphor Sleeves multi sizes
• 08717228442735: Hygienic Phosphor Sleeves Size 3
• 08717228442728: Hygienic Phosphor Sleeves Size 2
• 08717228442711: Hygienic Phosphor Sleeves Size 1
• 08717228442636: Hygienic Phosphor Sleeves Size 0
• 08717228440359: X-Ray sensor holder Refill Pack Endo Size 2, Content: 3x endo Upper Left / Lower Right - UDI 087
• 08717228440342: X-Ray sensor holder Refill Pack Endo Size 1, Content: 3x endo Upper Left / Lower Right - UDI 08
• 08717228440335: X-Ray sensor holder Refill Pack Periapical Size 2, Content: 5x periapical Upper Left / Lower Ri
• 08717228440328: X-Ray sensor holder Refill Pack Periapical Size 1, Content: 5x periapical Upper Left / Lower Ri
• 08717228440311: X-Ray sensor holder Refill Pack Posterior Size 2, Content: 5x posterior Upper Left / Lower Right
• 08717228440304: X-Ray sensor holder Refill Pack Posterior Size 1, Content: 5x posterior Upper Left / Lower Righ
• 08717228441042: X-Ray sensor holder Refill Pack Bitewing Size 2
• 08717228441035: X-Ray sensor holder Refill Pack Bitewing Size 1
• 08717228440274: X-Ray sensor holder Introduction Pack Size 2, content: 1x bitewing - UDI 08717228441042 1x post
• 08717228440267: X-Ray sensor holder Introduction Pack Size 1, content: 1x bitewing - UDI 08717228441035 1x poste
• 08717228441028: Positioning rings