FDA.reportPublic FDA data

N.A.

Primary DI
04049368119531
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
32004
Catalog number
32004
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
HNDSpatula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368119531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368119531040493681195314049368119531

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EP19A0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-03-24
B382S344901020Surgical DirectSurgical Direct, Inc.HND2026-03-09
G34EP223R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-02-27
G3446EP219SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-02-16
00757770636631Bausch + LombBausch & Lomb IncorporatedHND2026-02-04
05056785303367Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
B382S344901080Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344932020Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344961000Surgical DirectSurgical Direct, Inc.HND2026-02-04
05056785303343Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
00840319758540Hayden MedicalHayden Medical, Inc.HND2025-12-31
00840319758403Hayden MedicalHayden Medical, Inc.HND2025-12-24
00840319758410Hayden MedicalHayden Medical, Inc.HND2025-12-24
00852194002144HAI SpatulaHightech American Industrial Labs IncHND2025-12-16
G223M1129350Femtosecond SpatulaMedetz Surgical Instruments LLCHND2025-12-16
00757770676361Bausch + LombBausch & Lomb IncorporatedHND2025-12-12
B382S34543110T0Surgical DirectSurgical Direct, Inc.HND2025-12-10
B382S9344951010Surgical DirectSurgical Direct, Inc.HND2025-12-10
00757770695522Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770697892Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770688524Bausch + LombBausch & Lomb IncorporatedHND2025-11-14
B382S340861160Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S344101420Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S4088010Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9340311000Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9343771110Surgical DirectSurgical Direct, Inc.HND2025-11-11
G346EP55L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-26
G346EP1650Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-23
B382S9340861010Surgical DirectSurgical Direct, Inc.HND2025-09-22
G346EC222SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-18