FDA.reportPublic FDA data

N.A.

Primary DI
04049368061533
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
16080
Catalog number
16080
Device description
N.A.
Published
2021-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HODClamp, eyelid, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HODClamp, Eyelid, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368061533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368061533040493680615334049368061533

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316267202
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368016328N.A.38240382402021-02-23
04049368145219N.A.38210382102021-02-23
04049368145226N.A.38215382152021-02-23
04049368172505N.A.40006400062021-02-23
04049368172512N.A.40008400082021-02-23
04049368014201N.A.33960339602021-02-23
04049368015420N.A.38634386342021-02-23
04049368114154N.A.31306313062021-02-23
04049368127895N.A.32935329352021-02-23
04049368127925N.A.32936329362021-02-23
04049368127932N.A.32937329372021-02-23
04049368127994N.A.32944329442021-02-23
04049368133810N.A.33831338312021-02-23
04049368140818N.A.36282362822021-02-23
04049368141181N.A.36312363122021-02-23
04049368141631N.A.36364363642021-02-23
04049368141648N.A.36366363662021-02-23
04049368141655N.A.36368363682021-02-23
04049368169680N.A.32947329472021-02-23
04049368171423N.A.38606386062021-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HOD2026-08-07
00757770636099Bausch + LombBausch & Lomb IncorporatedHOD2026-04-30
00757770505715Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00757770505722Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00757770524426Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HOD2026-02-23
G2231139450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-11-05
G2231140730Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-09-05
00757770494071Bausch + LombBausch & Lomb IncorporatedHOD2025-08-15
G2231115290Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-08-11
00757770485574Bausch + LombBausch & Lomb IncorporatedHOD2025-08-08
G22312045700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-01-14
G223M12045670Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-01-14
00757770481811Bausch + LombBausch & Lomb IncorporatedHOD2024-12-30
00757770472277Bausch + LombBausch & Lomb IncorporatedHOD2024-11-21
G223147970530Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-09-19
G2231126320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-07-29
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00840183516703BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
G22312045620Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-05-23
G22312045660Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
G22312045670Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
00817524028157J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028164J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028171J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00841668135761ERHARDT LID FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135808BAIRD CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07