FDA.reportPublic FDA data

Badgley Mischka

Primary DI
00781096536658
Brand
Badgley Mischka
Company
MCGEE GROUP, INC., THE
Model
BM Davina Coffee
Catalog number
BMDAVI0CFE052S15
Device description
Spectacle Frame, Size 52-15-135
Published
2019-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQRApparatus, cautery, radiofrequency, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQRApparatus, Cautery, Radiofrequency, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00781096536658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781096536658007810965366587810965366580781096536658

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(770)442-0010dbeauchamp@mcgeegroup.com

Regulatory Flags#

DUNS number
847029543
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00781096115747Ducks UnlimitedDU Pulsar NavyDUPULS0NAV053S162019-10-25
00781096115754Ducks UnlimitedDU Pulsar GunmetalDUPULS0GUN053S162019-10-25
00781096115822Ducks UnlimitedDU Brant GunmetalDUBRAN0GUN048S192019-10-25
00781096115839Ducks UnlimitedDU Brant BrownDUBRAN0BRN048S192019-10-25
00781096115846Ducks UnlimitedDU Siege BlackDUSIEG0BLK053S162019-10-25
00781096115853Ducks UnlimitedDU Siege BrownDUSIEG0BRN053S162019-10-25
00781096115860Ducks UnlimitedDU Siege BlueDUSIEG0BLU053S162019-10-25
00781096115877Ducks UnlimitedDU Slingshot BlackDUSLIN0BLK055S182019-10-25
00781096115884Ducks UnlimitedDU Slingshot NavyDUSLIN0NAV055S182019-10-25
00781096115891Ducks UnlimitedDU Slingshot GunmetalDUSLIN0GUN055S182019-10-25
00781096115907Ducks UnlimitedDU Reserve BrownDURESE0BRN055S182019-10-25
00781096115914Ducks UnlimitedDU Reserve GunmetalDURESE0GUN055S182019-10-25
00781096115921Ducks UnlimitedDU Revolve BrownDUREVO0BRN056S162019-10-25
00781096115938Ducks UnlimitedDU Revolve GunmetalDUREVO0GUN056S162019-10-25
00781096115945Ducks UnlimitedDU Mason BrownDUMASO0BRN052S162019-10-25
00781096115952Ducks UnlimitedDU Mason BlackDUMASO0BLK052S162019-10-25
00781096115969Ducks UnlimitedDU Sharptail BlackDUSHAR0BLKS60S162019-10-25
00781096115976Ducks UnlimitedDU Sharptail TortoiseDUSHAR0TORS60S162019-10-25
00781096115983Ducks UnlimitedDU Sharptail Green TortoiseDUSHAR0TRGS60S162019-10-25
00781096116003Ducks UnlimitedDU Shield BrownDUSHIE0BRNS59S172019-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770636280Bausch + LombBausch & Lomb IncorporatedHQR2025-11-14
00757770430772Bausch + LombBausch & Lomb IncorporatedHQR2024-11-21
04049539100498DIATHERMY BIPOLAR CABLECarl Zeiss Meditec AGHQR2022-04-25
04049539100504DIATHERMY FORCEPSCarl Zeiss Meditec AGHQR2022-04-25
00757770423606Bausch + LombBausch & Lomb IncorporatedHQR2021-05-10
00781096115747Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115754Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115822Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115839Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115846Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115853Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115860Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115877Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115884Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115891Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115907Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115914Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115921Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115938Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115945Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115952Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115969Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115976Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115983Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116003Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116010Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116027Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116034Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116041Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116058Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25