Eberle 10-91313-55

GUDID B1921091313550

Aggressive Full Radius shaver blade 5.5 mm, C2

INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Arthroscopic shaver system blade, reusable

• Primary Device ID: B1921091313550
• NIH Device Record Key: 63698771-a4bc-43e0-abad-a4cf96853d82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eberle
• Version Model Number: 10-91313-55
• Catalog Number: 10-91313-55
• Company DUNS: 010741028
• Company Name: INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	B1921091313550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092977

FDA Product Code

• HRX: Arthroscope

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: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

• B1921091313550 - Eberle: 2023-06-16Aggressive Full Radius shaver blade 5.5 mm, C2
• B1921091313550 - Eberle: 2023-06-16 Aggressive Full Radius shaver blade 5.5 mm, C2
• B192300048000 - IEC-Innoview GmbH: 2023-06-16 10 mm, 70 deg. Laryngoscope, l=190 mm, autoclavable
• B192300049000 - IEC-Innoview GmbH: 2023-06-16 10 mm, 90 deg. Laryngoscope, l=190 mm, autoclavable
• B192300278000 - IEC-Innoview GmbH: 2023-06-16 8 mm, 70 deg. Laryngoscope, l=190 mm, autoclavable
• B192300083000 - IEC-Innoview GmbH: 2019-11-08 10.0 mm, 30 deg. Thoracoscope, l=170mm, autoclavable
• B192300003000 - IEC-Innoview GmbH: 2018-07-06 2.7 mm, 70 deg. Arthroscope, l=110mm, autoclavable
• B192300004000 - IEC-Innoview GmbH: 2018-07-06 2.7 mm, 0 deg. Arthroscope, l=175mm, autoclavable
• B192300006000 - IEC-Innoview GmbH: 2018-07-06 2.7 mm, 70 deg. Arthroscope, l=175mm, autoclavable