HYGENIC H07083C

GUDID D661H07083C1

6 METAL DAM FRAME

COLTENE/WHALEDENT INC

Rubber dam frame

• Primary Device ID: D661H07083C1
• NIH Device Record Key: 1cb86dcf-4a63-43b5-a314-66897a5d9a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYGENIC
• Version Model Number: H07083C
• Catalog Number: H07083C
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• 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: false
• 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
HIBCC	D661H07083C1 [Primary]

FDA Product Code

• EJE: Frame, Rubber Dam

Sterilization

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

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

[D661H07083C1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [HYGENIC]

• D661H027950: Fiesta Dam Clamp - #W2A Green
• D661H09966C1: FIESTA 9 COLOR CODED WINGED
• D661H09965C1: #14A WINGED FIESTA CLAMP
• D661H09964C1: #13A WINGED FIESTA CLAMP
• D661H09963C1: #12A WINGED FIESTA CLAMP
• D661H09962C1: #9 WINGED FIESTA CLAMP
• D661H09961C1: #8A WINGED FIESTA CLAMP
• D661H09960C1: #7 WINGED FIESTA CLAMP
• D661H09959C1: #4 WINGED FIESTA CLAMP
• D661H09958C1: #2A WINGED FIESTA CLAMP
• D661H09957C1: #2 WINGED FIESTA CLAMP
• D661H07792C1: 212 WINGLESS CLAMP
• D661H05690C1: #14 WINGED MOLAR CLAMP
• D661H05689C1: #3 WINGED MOLAR CLAMP
• D661H05688C1: #2A WINGED BICUSPID CLAMP
• D661H03815C1: W56 WINGLESS MOLAR CLAMP
• D661H03814C1: W3 WINGLESS MOLAR CLAMP
• D661H02803C1: #W56 WINGLESS FIESTA CLAMP
• D661H02802C1: #W14A WINGLESS FIESTA CLAMP
• D661H02801C1: FIESTA 9 COLOR CODED WINGLESS
• D661H02800C1: #W9 WINGLESS FIESTA CLAMP
• D661H02799C1: #W8A WINGLESS FIESTA CLAMP
• D661H02798C1: #W8 WINGLESS FIESTA CLAMP
• D661H02797C1: #W7 WINGLESS FIESTA CLAMP
• D661H02796C1: #W3 WINGLESS FIESTA CLAMP
• D661H02795C1: #W2A WINGLESS FIESTA CLAMP
• D661H02794C1: #W2 WINGLESS FIESTA CLAMP
• D661H02775C1: W2A WINGLESS BICUSPID CLAMP
• D661H02774C1: W14 WINGLESS MOLAR CLAMP
• D661H02770C1: W9 WINGLESS ANTERIOR CLAMP
• D661H02769C1: W00 WINGLESS BICUSPID CLAMP
• D661H02768C1: W2 WINGLESS BICUSPID CLAMP
• D661H02767C1: W8 WINGLESS MOLAR CLAMP
• D661H02766C1: W8A WINGLESS MOLAR CLAMP
• D661H02765C1: W7 WINGLESS MOLAR CLAMP
• D661H02764C1: W14A WINGLESS MOLAR CLAMP
• D661H02763C1: #9 WINGED ANTERIOR CLAMP
• D661H02762C1: #00 WINGED BICUSPID CLAMP
• D661H02761C1: #2 WINGED BICUSPID CLAMP
• D661H02760C1: #8 HYG WINGED MOLAR CLAMP
• D661H02759C1: #8A HYG WINGED MOLAR CLAMP
• D661H02758C1: #7 HYG WINGED MOLAR CLAMP
• D661H02757C1: #14A HYG WINGED MOLAR CLAMP
• D661H02706C1: #12A HYG WINGED CLAMP
• D661H02705C1: #13A HYG WINGED CLAMP
• D661H02704C1: #4 HYG WINGED CLAMP
• D661H02703C1: #1 HYG WINGED CLAMP
• D661H02701C1: SYSTEM 9 CLAMP PAK
• D661H01054C1: HYG TISSUE RETRACTORS
• D661H01053C1: B 6 HYG TISSUE RETRACTOR