FDA.reportPublic FDA data

Safco Safewrap barrier film

Primary DI
D72310227703
Brand
Safco Safewrap barrier film
Company
SAFCO DENTAL SUPPLY CO.
Model
1022770
Catalog number
1022770
Device description
SafeWrap Barrier Film Clear 4x6 1200
Published
2022-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D72310227703PrimaryHIBCC0
D72310227700Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
020417380
Device count
1200
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D72310203523Prep&Etch™102-0352102-03522016-08-17
D72310203603Prep&Etch™102-0360102-03602016-08-17
D72310202123Safco TruCheck102021210202122022-06-17
D72310202133Safco TruCheck102021310202132023-07-31
D72310202153Safco TruCheck102021510202152022-06-17
D72310202173Safco TruCheck102021710202172022-06-17
D72310202183Safco TruCheck102021810202182023-07-31
D72310202193Safco TruCheck102021910202192022-06-17
D72310202213Safco TruCheck102022110202212022-06-17
D72310224053Safco Pure102240510224052022-03-30
10810063756243KIDS BUDDY Toothbrush8250071TK32025-03-19
10810063756250Power Curve Toothbrush82500830022025-03-19
10810063756267Esprit Ultra Fine Toothbrush82500872082025-03-19
10810063756274Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
10810063756281Power Curve Toothbrush8250093002-I2025-03-19
10810063756403Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
10810063756434KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
10810063756588Jr Series Comfort Grip Toothbrush82500892402025-03-19
10810063756595Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125780MLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780MW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
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