Prehma 1017110

GUDID H66810171101

Surgical Cone Masks Pink

Keystone Industries

Surgical/medical face mask, single-use

• Primary Device ID: H66810171101
• NIH Device Record Key: da05d86b-c84f-4bc1-8d15-d9e6104d7930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prehma
• Version Model Number: 1017110
• Catalog Number: 1017110
• Company DUNS: 073503117
• Company Name: Keystone Industries
• Device Count: 50
• DM Exempt: false
• 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: false
• 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: true

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66810171100 [Unit of Use]
HIBCC	H66810171101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023755

FDA Product Code

• FXX: Mask, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Prehma]

• H66810186101: Optima Ear Loop Procedural Masks Pink
• H66810185101: Surgical Tie-On Masks Blue
• H66810184101: Optima Ear Loop Procedural Masks Green
• H66810182101: Procedural Ear Loop Masks Green
• H66810180101: Procedural Ear Loop Masks Blue
• H66810171101: Surgical Cone Masks Pink
• H66810170101: Surgical Cone Masks Blue
• H66879020000: Prehma Saliva Ejectors Wht/Wht Tip Case 10/100
• H66870039990: Prehma D3 HVE Tips White Bag/50
• H66836011220: Mylar strips (Tube x 1000)
• H66836010220: Mylar Strips (Tube X 100)
• H66827013100: SURGICAL BLADES CS #25 ( BX X 100 )
• H66827011100: SURGICAL BLADES CS #24 ( BX X 100 )
• H66827007100: SURGICAL BLADES CS #20 ( BX X 100 )
• H66827005100: SURGICAL BLADES CS #15 ( BX X 100 )
• H66827003100: SURGICAL BLADES CS #12 ( BX X 100 )
• H66827002100: SURGICAL BLADES CS #11 ( BX X 100 )
• H66827001100: SURGICAL BLADES CS #10 ( BX X 100 )
• H66819022121: MATRIX RETAINER CHILD ( EA )
• H66819021121: MATRIX RETAINER ADULT ( EA )
• H66819020121: MATRIX RETAINER UNIV ( EA )
• H66819008120: MATRIX BAND #13 0.015 ( BAG X 12 )
• H66819007120: MATRIX BAND #3 0.015 ( BAG X 12 )
• H66819006120: MATRIX BAND #2 0.015 ( BAG X 12 )
• H66819005120: MATRIX BAND #1 0.015 ( BAG X 12 )
• H66819004120: MATRIX T-BAND LG X100 ( BAG X 100 )
• H66819003120: MATRIX T-BAND SM X100 ( BAG X 100 )
• H66819002121: MATRIX ROLL 1/4 0.015 ( BX X 10FT )
• H66819001121: MATRIX ROLL 3/16 0.015 ( BX X 10FT )
• H66812012100: PREHMA SURGICAL ASPIRATOR 1/16 ( BAG X 25)
• H66812011100: PREHMA SURGICAL ASPIRATOR 1/8 ( BAG X 25)
• H66812010100: PREHMA SURGICAL ASPIRATOR 1/4 ( BAG X 25)
• H66812002100: PREHMA SALIVA EJECTORS WHITE BAG X 100
• H66812001100: PREHMA SALIVA EJECTORS CLEAR BAG X 100
• H66810053100: SYRINGE SLEEVE CLEAR (BX X 500)- Barrier Item
• H66810052100: SYRINGE SLEEVE BLUE (BX X 500)- Barrier Item
• H66810051100: BARRIER FILM BLUE (BX X 1200)
• H66810050100: BARRIER FILM CLEAR (BX X 1200)
• H66810047100: Disposable Air/Water SyringeTips Assorted (250/bag)
• H66810045100: Disposable Air/Water Syringe Tips White (250/bag)
• H66805816480: CARBIDE BUR PREHMA FG 8 100 PK
• H66805813480: Carbide Bur Prehma FG 330 100 PK
• H66805811480: CARBIDE BUR PREHMA FG 245 100 PK
• H66805805480: CARBIDE BUR PREHMA FG 556 100 PK
• H66805804480: CARBIDE BUR PREHMA LA 4 100 PK
• H66805678480: CARBIDE BUR PREHMA SC 199Z 10 PK
• H66805646480: CARBIDE BUR PREHMA LA 8 10 PK
• H66805638480: CARBIDE BUR PREHMA LA 700 10 PK
• H66805635480: CARBIDE BUR PREHMA LA 6 10 PK
• H66805628480: CARBIDE BUR PREHMA LA 557 10 PK