FDA.reportPublic FDA data

Badgley Mischka

Primary DI
00781096531202
Brand
Badgley Mischka
Company
MCGEE GROUP, INC., THE
Model
BM Lolie Tortoise
Catalog number
BMLOLI0TOR053S16
Device description
Spectacle Frame, Size 53-16-135
Published
2019-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00781096531202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781096531202007810965312027810965312020781096531202

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
Premarket exempt
true

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