Prehma 1018510

GUDID H66810185101

Surgical Tie-On Masks Blue

Keystone Industries

Surgical/medical face mask, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

Primary Device ID	H66810185101
NIH Device Record Key	6edcbd49-fbe3-40be-a72b-f3b27518710e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Prehma
Version Model Number	1018510
Catalog Number	1018510
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	H66810185100 [Unit of Use]
HIBCC	H66810185101 [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