FDA.reportPublic FDA data

N.A.

Primary DI
04049368061458
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
16060
Catalog number
16060
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
04049368061458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368061458040493680614584049368061458

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368058045N.A.154902023-07-06
04049368058199N.A.155202023-07-06
04049368055662N.A.15095150952021-07-05
04049368055693N.A.15096150962021-07-05
04049368055938N.A.15125151252021-07-05
04049368055952N.A.15130151302021-07-05
04049368056119N.A.15141151412021-07-05
04049368056157N.A.15151151512021-07-05
04049368056263N.A.15180151802021-07-05
04049368056348N.A.15188151882021-07-05
04049368056386N.A.15189151892021-07-05
04049368056423N.A.15190151902021-07-05
04049368056447N.A.15195151952021-07-05
04049368056638N.A.15240152402021-07-05
04049368056690N.A.15250152502021-07-05
04049368056799N.A.15270152702021-07-05
04049368056812N.A.15271152712021-07-05
04049368056850N.A.15273152732021-07-05
04049368061823N.A.16105161052021-07-05
04049368061847N.A.16106161062021-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G2231140730Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-09-05
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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
G22312045690Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-07-01
G223119354A0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-06-17
00840183509040BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
00840183509057BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
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
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00841668135815DESMARRES CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135822FRANCIS CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135839HUNT CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135846LAMBERT CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135853LORDAN CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135860WIES CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135877MONTOYA MULLERECTOMY FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07