FDA.report

N.A.

Primary DI
04049368058816
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
15660
Catalog number
15660
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

Related Records

Product Codes

CodeName
HNBSpoon, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNBSpoon, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049368058816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049368058816040493680588164049368058816

GMDN Terms

TermDefinition
Lens spoonA hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. This is a reusable device.

Sterilization Methods

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

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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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00841668129388GROOVED DONOR SPOONKATENA PRODUCTS, INC.HNB2022-12-07
00841668129876LEWIS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668129920MORRISON LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668129975NEW ORLEANS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130018KANSAS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130025WILDER LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130063BARRAQUER LENTICULAR SPOONKATENA PRODUCTS, INC.HNB2022-12-07
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